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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 16.0-999.0, Syncope Age > = 16 yrs Acute syncope presentation to MAU or A+E or more unexplained syncopes within the past 24 months including index episode Normal baseline ECG Absence of co existing pathology requiring admission Suspected or known heart disease ECG abnormalities suspected of arrhythmic syncope listed in Table 1 Syncope occurring during exercise Syncope causing severe injury Family history of sudden death Sudden onset palpitations prior to syncope Table 1: ECG Abnormalities Bifascicular block (defined as LBBB or RBBB combined with left anterior or left posterior fascicular block) Other intraventricular abnormalities (QRS duration >= 0.12s) Mobitz 1 second degree AV block (Wenckebach) Asymptomatic sinus bradycardia (<50 bpm), SA node or sinus pause >= 3s in the absence of negatively chronotropic medications
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1
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Coronary Heart Disease Congestive Heart Failure Ventricular Dysfunction Low Cardiac Output Sudden Cardiac Death documented chronic coronary heart disease (prior MI and/or angiographically documented CAD), > 40 days post the most recent MI LVEF < 40% (by MUGA) and NYHA functional class II or III at time of assessment OR LVEF ≤ 35 % (by MUGA) and NYHA functional class I, II or III at time of assessment Judged to have a reasonable expectation of survival with a good functional status for more than 1 year, as well as receiving optimum, guideline recommended therapy for coronary artery disease and heart failure (or demonstrated intolerance or contraindications to such therapy) Age ≥ 18 years; no upper age limitation Prior cardiac arrest, sustained VT or VF, or unexplained syncope Attempted VT / VF induction at electrophysiological study Need for a cardiac resynchronization therapy (CRT) device Enrollment in another interventional trial
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1
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Heart Failure Central Sleep Apnea Patients with documented clinical history of symptomatic but stable congestive heart failure, NYHA III or NYHA IV, of at least six weeks duration Patient has an indication for a CRT device, or patients with previous pacemaker indication, except Sick Sinus Syndrome, and currently in need for an upgrade to a CRT device Patient is scheduled for the implantation of a CRT device Patient is over 18 years of age Patient provides Informed Consent Inability to complete overnight sleep study as specified by the protocol Myocardial infarction or coronary revascularization procedure within 2 calendar months prior to enrollment Planned or strong likelihood of cardiac surgery within 4 months following enrollment A spirometric confirmation of obstructive lung disease Evidence of obstructive sleep apnea at baseline polysomnography Body mass index >30 kg/m² Pregnant women
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 21.0-999.0, Atrial Fibrillation >=21 years of age a history of atrial fibrillation a history of at least two occurrences of atrial fibrillation or atrial flutter, at least one of which is atrial fibrillation an electrocardiogram that was recorded within 12 months of randomization showing atrial fibrillation or atrial flutter sinus rhythm at the time the first dose of randomized medication is taken stable antiarrhythmic medications if the patient has had an ablation for atrial fibrillation or flutter or a MAZE procedure, the qualifying episode of atrial fibrillation must have occurred at least 3 months post-procedure normal serum potassium level within the last 28 days provided informed consent permanent atrial fibrillation or flutter New York Heart Association class III or IV heart failure or Canadian Cardiovascular Society class III or IV angina pectoris cardiac or thoracic surgery within the previous 3 months acute pericarditis within the previous 3 months other reversible causes of atrial fibrillation such as thyrotoxicosis acute myocardial infarction or unstable angina within the previous 3 months history of neurologic event (TIA or stroke)within the past 3 months history of acute congestive heart failure precipitated by atrial fibrillation, and the patient is not receiving rate-control therapy Wolff-Parkinson-White syndrome a medical condition that is likely to be fatal in less than one year
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 50.0-999.0, Erectile Dysfunction Male patients at least 50 years erectile dysfunction dissatisfaction with their use of a phosphodiesterase-5 inhibitor coronary artery disease (or at risk for coronary artery disease) undergoing diagnostic cardiac catheterization or patients with peripheral vascular disease undergoing peripheral arteriography Patients who respond favorably to phosphodiesterase-5 inhibitors known non-vascular etiologies of their erectile dysfunction probable neurogenic erectile dysfunction due to radiation injury, surgery, or transurethral resection of the prostate calculated GFR < 60 ml/min/1.73 m2 will also be excluded disease that necessitates complex percutaneous intervention will be excluded per the investigators discretion
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 21.0-999.0, Ventricular Tachycardia Age > 21 years Prior myocardial infarction Scheduled for CT scan < 1 week prior to VT ablation for ventricular arrythmia Serum creatinine > 1.8 mg/dL Contrast dye allergy Atrial fibrillation Unable to lie flat for the duration of image acquistion (15-20 minutes) Clinical instability at time of CT study acquisition Women of childbearing potential Personal or social problems that might prevent compliance with the study
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Ventricular Tachycardia, Monomorphic ICD indication for reason of survived cardiac arrest, ventricular tachycardia or syncope ICD indication for reason of non-sustained VT post MI, positive family history for SCD (Brugada-, long/short QT-Syndrome), hypertrophic cardiomyopathy, primary prophylactic indication (e.g. SCD-HeFT, Madit II) Patients not capable of participating in the follow-ups Minors and pregnant women Patients who are already enrolled in another study
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Atrial Fibrillation Patients age 18 or older Patients with paroxysmal AF symptomatic and refractory to at least one antiarrhythmic medication In patients with paroxysmal AF, at least one episode of AF must have been documented by ECG or Holter within 12 months of randomization in the trial Patients with persistent AF defined as a sustained episode that had been present for more than seven days without intervening spontaneous episodes of sinus rhythm and that recurred within seven days after cardioversion Patients with persistent AF must be on continuous anticoagulation with warfarin (INR 2-3) for> 4 weeks prior to ablation. In patients with paroxysmal AF no continuous anticoagulation therapy with warfarin for > 4 weeks prior to ablation will be needed provided a transesophageal echocardiogram performed prior to ablation the presence of thrombi or other abnormalities that discourage performing the procedure Patients must be able and willing to provide written informed consent to participate in the clinical trial Patients with AF secondary to reversible causes Patients with inadequate anticoagulation levels as defined in the criteria Patients with left atrial thrombus, tumor, or another abnormality which precludes catheter introduction on TEE prior to the procedure Patients with contraindications to systemic anticoagulation with heparin or coumadin Patients who have previously undergone atrial fibrillation ablation, either by surgery or by percutaneous catheter Patients with left atrial size > 55 mm Patients who are or may potentially be pregnant Patients with hyperthyroidism or hypothyroidism Current enrollment in another investigational drug or device study Pacemaker or Implantable Cardioverter Defibrillator
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Acute Coronary Syndrome Chest Pain Age greater than or equal to 18 years of age at the time of enrollment Chest discomfort or other symptoms consistent with possible Acute Coronary Syndrome (ACS) as indicated by the treating physician after obtaining an Electrocardiogram (ECG) and cardiac biomarkers for the patient's evaluation Patient requires an inpatient evaluation for their chest pain The treating physician feels the patient could be discharged home if cardiac disease was excluded Thrombolysis in Myocardial Infarction (TIMI) risk score ≥ 2 OR physician clinical impression of intermediate or high likelihood that the symptoms represent ACS Negative pregnancy test (if sexually active, female, and of childbearing age) Initial troponin I > 1.0 ng/ml New ST-segment elevation on any electrocardiogram (≥ 1 mV) New ST-segment depression on any electrocardiogram (≥ 2 mV) Unable to lie flat Hypotension (systolic < 90 mm Hg) Contra-indications to MRI(Pacemaker, defibrillator, cerebral aneurysm clips, metallic ocular foreign body, implanted devices, claustrophobia) Patient refusal of medical record review and telephone follow-up at 30 days Terminal diagnosis with life expectancy less than 3 months Pregnancy per patient report or positive pregnancy test (Center for Medicare & Medicaid Services (CMS) Renal insufficiency(done prior to enrollment)or end stage renal disease
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Transitional Cell Carcinoma of the Bladder Histological proof of muscle-invasive transitional cell carcinoma of the bladder (stage II-IVa) with no evidence of metastatic disease (focal squamous and/or adenocarcinoma differentiation defined as ≤ 10% of tumor volume allowed, sarcomatoid and small-cell components not allowed). Patient with any degree of fixation of the pelvic sidewall are not eligible Patients must be willing to undergo a Cystoscopy, prior to registration on study if tumor block is not available Eligible for radical cystectomy as per the attending urologist All patients must be willing to forego neoadjuvant cisplatin-based combination chemotherapy and understand it is an option post-surgery or must be deemed ineligible for cisplatin-based combination chemotherapy by the attending medical oncologist Prior radiation therapy is allowed provided that no radiation therapy was administered to the urinary bladder Written informed consent and HIPAA authorization for release of personal health information Age > 18 years at the time of consent Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 4 weeks after treatment discontinuation Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy Females must not be breastfeeding No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, Gleason < grade 7 prostate cancers, or other cancer for which the patient has been disease-free for at least 5 years No treatment with any investigational agent within 30 days prior to being registered for protocol therapy No prior systemic chemotherapy for transitional cell carcinoma of the bladder( prior intravesical therapy is allowed). Any other prior chemotherapy must have been completed > 5 years prior to initiation of therapy Following concomitant medications must be discontinued 7 days prior to registration on study and for the duration of dasatinib therapy: Bisphosphonates due to risk of hypocalcemia; Drugs that are generally accepted to have a risk of causing Torsades de Pointes; any prohibited CYP3A4 inhibitors/inducers/substrates; Anti-coagulation and/or anti-platelet therapies to avoid potential bleeding risks No clinically significant infections as judged by the treating investigator No pleural or pericardial effusion of any grade history of diagnosed congenital bleeding disorders (e.g., von Willebrand's disease) No history of diagnosed acquired bleeding disorder (e.g., acquired anti-factor VIII antibodies) within one year prior to registration on protocol therapy No history of ongoing or recent (within <3 months prior to registration on protocol therapy) significant gastrointestinal bleeding
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Sleep Apnoea Patients who are at risk of sudden death due to ventricular arrhythmia and who satisfy at least one of the following are eligible for enrolment Class I indications for ICD Survival of at least one episode of cardiac arrest due to VT or VF not due to a transient or reversible cause, or presumed to be due to VF when electrophysiological testing is precluded by other medical conditions; or Spontaneous sustained ventricular tachycardia, or Syncope of undetermined origin with clinically relevant haemodynamically significant sustained VT or VF induced at electrophysiological study when drug therapy is ineffective, not tolerated or not preferred, or Class IIa Indication for ICD Non-sustained VT with coronary disease, prior myocardial infarction, left ventricular dysfunction (≤ 40%) and inducible VF or sustained VT at electrophysiological study With prior myocardial infarction and LVEF less than 30 % (without prior life-threatening arrhythmia or sustained VT) Patients candidate for cardiac resynchronization therapy (CRT) need to be in functional Class III or IV of the NYHA classification. Patients will be included only after having granted their informed consent to participate in the study, preceded by the delivery of appropriate information VT/VF is associated with drug toxicity, electrolyte imbalance, hypoxia, electrocution or other reversible cause VT/VF occurred during the acute phase of infarction (< 1 week) or during an unstable ischemic phase Incessant VT/VF Implanted pacemaker that is not going to be explanted or otherwise disabled Inability or refusal to provided informed consent Tricuspid valvular disease or tricuspid mechanical heart valve (lead contraindication) Unable to understand the purpose and plan of the study Geographically unstable or not available for follow-up as defined in the investigational plan Reduced life expectancy (≤ 1 year) for other than cardiovascular reasons Patient participating in another clinical study
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 0.0-999.0, Syncope Presyncope Fainting Cardiac Arrhythmia Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias Patients who experience transient symptoms that may suggest a cardiac arrhythmia Patients that have had a myocardial infarction (MI) < 30 days prior to implant
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-99.0, Ventricular Tachycardia Current treatment with amiodarone Ischemic or non-ischemic cardiomyopathy Monomorphic ventricular tachycardia at any cycle length, with > 1 occurrence of the same cycle length and morphology, at least one episode needs to be of sufficient duration to result in a shock No contraindication to up titration of meds or to VT radiofrequency ablation (RFA) Primary antiarrhythmic medication other than amiodarone Amiodarone at dose of 600 mg daily or higher Polymorphic VT as culprit rhythm History of metal exposure (welding) Pregnant women Recent myocardial infarction
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-85.0, Heart Failure, Congestive Death, Sudden, Cardiac Arrhythmia Cardiomyopathies History of acute MI at least 4 weeks old Non-ischemic LV dysfunction for at least 9 months Who have an EF < or = to 35% Undergone ERI generator replacement of an FDA-approved ICD for primary prevention of SCD within 24 months of enrollment Who have primary prevention implants ICD generator replacement for secondary prevention Inability or unwillingness to provide valid informed consent New York Heart Association Class IV heart failure Patients with pre-existing Class 1 indications for pacemaker therapy
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Tachyarrhythmias Syncope Patients who have clinical syndromes or situations at increased risk of cardiac arrhythmias Patients who experience transient symptoms that may suggest a cardiac arrhythmia Patients who have been previously diagnosed with atrial fibrillation Patients who are suspected to have Atrial Fibrillation (AF) but AF has not been documented Patients who have provided written informed consent to participate in the study Patients who are under the age of 18 years Patients who have a life expectancy less than 1 year Patients who are unable to comply with the follow-up schedule Patients who are currently implanted with a pacemaker or defibrillator Patients who the physician deems inappropriate for the study
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Syncope All adult patients (age 18 or older) admitted with syncope or near-syncope Patients who do not speak/read the language of the consent form Prisoners Patients who are of altered mental status or had head trauma Refusal or inability to sign consent
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-75.0, Sleep Apnea Ventricular Arrythmias Systolic Left Ventricle Dysfunction Previous diagnostic of ischaemic heart disease of dilated myocardiopathy Ejection fraction of left ventricle < 40% Patients with implantable cardioverter-defibrillator Diurnal hypersomnolence with EES > 16 Morbid obesity (BMI > 35 Kg/m2) Moderate-severe chronic obstructive pulmonary disease (FEV1/FVC < 70 % and FEV1 < 80 % of reference) Known thyroid disease Previous treatment with CPAP
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 15.0-70.0, Asthma Patient is male or female, at least 15 years of age and no more than 70 years Patient has mild persistent asthma (step 2) of the Guidelines for the Diagnosis and Management of Asthma issued by the National Heart, Lung, and Blood Institute of the National Institutes of Health as defined by a history of symptoms at least once a week but less than daily (step 2) (5) Current asthma treatment includes short-acting inhaled β-agonist alone as needed Patient fulfils all the following signs and symptoms of asthma History of symptoms including, but not limited to dyspnea, wheezing, chest tightness, cough, or sputum production for at least 12 months A forced expiratory volume in one second (FEV1) of at least 80% of the predicted value (pre-bronchodilator) while withholding β-agonist for at least six hours Patient has a diagnosis of asthma as defined by 1) an increase in FEV1 or PEF of ≥12% (absolute value), 20 to 30 minutes after inhaled β-agonist administration, OR 2) a positive methacholine PC20 (provocative concentration causing a 20% fall in FEV1) of 8 mg/ml or lower which was performed within the previous 12 months, OR 3) a fall in FEV1 of at least 15% after an exercise challenge which was performed within the previous 12 months. β-agonist reversibility and the methacholine and exercise challenge tests may be satisfied within the previous 12 months if there is adequate source documentation Patients demonstrate symptoms requiring β-agonist use on ≥2 and ≤6 days of the week for the previous two weeks Patient is able to chew a tablet Patient is judged to be in good, stable physical and mental health (except for his/her asthma) based on the medical history, physical examination, and routine laboratory data, and appears able to successfully complete this trial none
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 35.0-999.0, Acute Chest Pain patients who complain of typical or atypical chest pain (that is compatible with ischemia during the past 12 hrs) patients a prediction of low to intermediate risk of myocardial infarction and/or complications according to established criteria patients who have normal or non-diagnostic electrocardiograms patients who have negative cardiac biomarker including creatine kinase-MB, myoglobin, and/or cardiac troponin I at initial testing; patients who require admission to the hospital by the EP at the time of risk-stratification patients who require cardiology consultation in the ED 7. patients who are age 35 years or older patients who are able to hold their breath for ≥ 15 seconds (to obtain a quality static anatomical image, scanning requires at least fifteen seconds of breath holding patients who have heart rate of < 70 beats per minute before or after the administration of beta-blocker medication patients who have a contraindication to iodinated and/ or beta-blocking drugs; patients who have compromised renal function defined as creatinine ≥ 1.2 mg/dl patients who are pregnant, suspected pregnant or other vulnerable populations e.g., incarcerated patients patients who have documented CAD by prior invasive coronary angiography or coronary CT angiography and/or patients with coronary artery stents, prior angioplasty, or prior coronary artery bypass grafts (CABG) patients who have had prior cardiac imaging (within the past year) with normal result including invasive coronary angiography, coronary CT angiography, or nuclear stress testing patients who are unstable; patients who have an electrocardiogram diagnostic of ischemia or myocardial infarction (significant Q waves, ST -segment deviations > 0.5 mm, or T wave inversions) patients in atrial fibrillation or have markedly irregular rhythm 9. patients who have had contrast administration within the past 24hrs patients without an 18 gauge antecubital intravenous access; patients who have a medical home outside of the Medical system
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1
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Atrial Fibrillation Age ≥18 years Sinus rhythm at the time of enrollment as documented by ECG, telemetry, or Holter monitoring Scheduled for an open heart surgery Able to provide informed consent Systemic inflammatory diseases (e.g., collagen vascular diseases, infections) Malignant neoplasms Hyperthyroidism Uncontrolled hypertension (blood pressure > 180/100 at rest) on medications An illness that might result in death within 1 year Implanted devices for designed for active management of atrial arrhythmias by pacing or defibrillation Current illicit drug use Current ethanol abuse Presence of paroxysmal, persistent, or permanent atrial fibrillation at the time of enrollment
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 55.0-999.0, Stroke Transient Ischemic Attack Atrial Fibrillation Atrial Flutter Diagnosis of the index event* made by a stroke specialist of an acute ischemic stroke or TIA (WHO definition) of undetermined etiology (cryptogenic) occurring within the previous 6 months (180 days).The event must be either an embolic arterial ischemic stroke confirmed by neuroimaging; or a transient ischemic attack, defined as involving a focal unilateral motor deficit, speech/language deficit, or hemianopia, with symptom duration <24 hours (note: amaurosis fugax/transient monocular blindness, pure sensory spells, isolated vertigo spells, etc. do not qualify for enrolment given the potential for misdiagnosis of such events). 2. Patient meets the following At least one 12-lead ECG has already been obtained as part of the routine clinical post-stroke/TIA work-up, and no ECGs have shown any episodes of atrial fibrillation or atrial flutter, and A Holter monitor has already been obtained as part of the routine clinical post-stroke/TIA work-up, and does not show any episodes of atrial fibrillation or atrial flutter ≥30 seconds. 3. The patient is being actively investigated for the etiology of the stroke/TIA event and additional cardiac monitoring is desired to screen further for the possibility of occult paroxysmal atrial fibrillation/flutter, i.e. patients selected for this study are those for whom the investigator, in his/her clinical judgment, would consider ordering a repeat Holter monitor as part of clinical care. 4. The following diagnostic tests have already been completed as part of clinical routine post-stroke/TIA brain imaging with CT or MRI vascular imaging of the extracranial and intracranial circulation with either CT angiography or MR angiography to significant large vessel occlusive disease as the most likely mechanism for the index ischemic event (carotid Doppler ultrasound is acceptable for those presenting with anterior circulation ischemic events) transthoracic (or transesophageal) echocardiography to thrombus or other structural heart disease that in the opinion of the investigator is the most likely cause for the stroke/TIA event. [Note: If a baseline echocardiogram cannot be obtained clinically after the index event and prior to study enrollment, then it is acceptable for study purposes for an echocardiogram to be obtained after patient enrollment into the study but prior to the 90-day follow-up visit. Alternatively, an echocardiogram already performed within one year prior to study enrollment may serve as the baseline echocardiogram for study purposes.] 5. Age 55 years or older [Note: Participants aged 55-59 years should have imaging confirmation of the index stroke/TIA event with an embolic imaging pattern of acute cerebral ischemia] 6. Informed consent from the patient (or from a legally authorized representative if the patient is not competent, e.g. due to stroke-related cognitive impairment, aphasia, or anosognosia). 7. The patient is expected to survive at least 6 months. 8. The patient has a valid provincial health insurance number The index event will be defined as the event leading to medical presentation 1. Any previously documented atrial fibrillation or atrial flutter, i.e. a past history of atrial fibrillation/flutter or atrial fibrillation/flutter detected on ECG, Holter, or telemetry following the index stroke/TIA event (a remote history of transient perioperative atrial fibrillation is not exclusionary 2. Exclusively retinal stroke or TIA event. 3. A most responsible etiological diagnosis for the qualifying stroke/TIA event has already been determined, i.e. probable small-vessel (lacunar) disease, probable large vessel disease, cervicocephalic artery dissection, venous sinus thrombosis, hypercoagulable states, or other known cause. 4. Planned carotid endarterectomy within 90 days. 5. Patient is already currently participating in a clinical trial involving an investigational medication or device.* 6. Any finding on echocardiography for which there is already an evidence-based indication for long-term anticoagulation (e.g. mechanical heart valve, thrombus, etc.). 7. Endocarditis 8. Pacemaker or ICD device. 9. Patients with known skin reactions to synthetic polymers or to silver. (Some people who display sensitivity to silver jewellery are sensitive to the impurities present in silver alloys and not to the silver itself. These people may participate.)
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-80.0, Ventricular Tachycardia Coronary Artery Disease Left Ventricular Dysfunction Coronary artery disease For the purpose of this study, coronary artery disease will be defined as the presence of a 50 % or more diameter stenosis of the left main coronary artery, or 75 % or more diameter stenosis of the left anterior descending, circumflex or right coronary arteries, or the history of a surgical or percutaneous revascularization procedure, or history of successful thrombolysis, or a history of prior myocardial infarction (e.g.: documented by Q-wave, R-reduction, aneurysm) Left ventricular ejection fraction ≤ 50 % as estimated by echocardiography or contrast ventriculography within the previous 30 days and evidence for old myocardial infarction (ECG, echocardiographic or venticulographic) One episode of documented stable clinical VT without any reversible causes Written informed consent Age < 18 years or > 80 year Protruding LV thrombus on pre-ablation echocardiogram Acute myocardial infarction within the preceding 1 months Class IV NYHA heart failure Valvular heart disease or mechanical heart valve precluding access to the left ventricle Unstable angina Cardiac surgery involving cardiotomy (not CABG) within the past 2 months Serum creatinine > 220 mmol/L (2.5 mg/dL) Thrombocytopenia or coagulopathy Contraindication to heparin
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 40.0-999.0, Cryptogenic Symptomatic Transient Ischemic Attack Cryptogenic Ischemic Stroke Recent cryptogenic symptomatic transient ischemic attack (TIA) or cryptogenic ischemic stroke Known etiology of TIA or stroke. 2. Untreated hyperthyroidism. 3. Myocardial infarction less than 1 month prior to stroke or TIA. 4. Coronary bypass grafting less than 1 month prior to stroke or TIA. 5. Valvular disease requiring immediate surgical intervention. 6. History of AF or atrial flutter. 7. Patent Foramen Ovale (PFO) and PFO is or was an indication to start oral anticoagulation (OAC). 8. Permanent indication for OAC at enrollment. 9. Permanent contra-indication for OAC. 10. Included in another clinical trial. 11. Life expectancy less than 1 year. 12. Pregnant. 13. Indicated for Implantable Pulse Generator (IPG), Implantable Cardioverter-Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT) or an implantable hemodynamic monitoring system. 14. Not fit, unable or unwilling to follow the required procedures of the protocol
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Ischemic Ventricular Tachycardia Patient is 18 years of age or older Patient has an ICD (Implantable Cardiac Defibrillator) or will be implanted with one prior to discharge of ablation procedure Patient has had at least 2 documented spontaneous episode of sustained ischemic VT (Ventricular Tachycardia) within the previous 6 months Patient is resistant, intolerant or refractory to at least one Class I or III AAD (Anti-Arrhythmic Drug) Patient has been informed of the nature of the study and has agreed to its provisions and provided written informed consent approved by the Institutional Review Board Non-ischemic VT History of stroke or transient ischemic attack within 6 months prior to enrollment MI or previous cardiac surgery within 2 months prior to enrollment Patient is pregnant or nursing Patient has chronic NYHA (New York Heart Association) class IV heart failure Limited life expectancy of 6 months or less Patient is currently participating in another investigational drug or device study Patient is unable or unwilling to cooperate with the study procedures Known presence of intracardiac thrombi Severe aortic stenosis or flailed mitral valve
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Stroke Age > 18 years Seen at UCSF Medical Center for cryptogenic stroke or high-risk TIA Onset of stroke or TIA symptoms within the previous 60 days Definite small-vessel etiology by history or imaging Source found on vascular imaging of possible culprit vessels Source found by echocardiography (TEE not required) History of atrial fibrillation Atrial fibrillation on admission ECG Atrial fibrillation detected by inpatient cardiac telemetry (at least 24 hours required) Obvious culpable systemic illness such as endocarditis Patient unable to provide written, informed consent
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Burns Thermal burn occurring within the 96 hours prior to dosing Inability to obtain informed consent (or assent from surrogate) Less than 18 years of age Patient or surrogate not committed and/or not likely to remain committed to full support, as, for example, would be the case for a patient with end-stage cancer or other end-stage terminal conditions. Commitment to full support need not cardiopulmonary resuscitation provided the team is committed to other forms of full support Unable to receive or absorb enteral study drug Statin specific exclusions Receiving a statin medication within 48 hours of dosing (to controls from exposure to statins) Allergy or intolerance to statins ALT or AST > 5 times upper limit of normal Untreated hypothyroidism by history (package insert) Pregnancy or breastfeeding
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 50.0-999.0, Syncope Age≥60 years A complaint of syncope or near-syncope (Syncope is defined as a sudden, transient loss of consciousness. Near-syncope is defined as a sensation of imminent loss of consciousness, without actual syncope.) Intermediate risk of adverse outcome (see Table) Patient speaks either English or Spanish as a primary language Syncope mimics (intoxication, weakness or dizziness with syncope/ near-syncope, hypoglycemia, and cardiac arrest) New or baseline cognitive impairment or dementia) Inability to provide follow-up information (e.g. homeless or resides outside of U.S.) Inability to speak Spanish or English Low and high-risk patients (see Table). Risk Stratification Guidelines High Risk Serious condition identified in ED History of ventricular arrhythmia Cardiac Device with dysfunction
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1
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 0.0-999.0, Arrhythmias, Cardiac Bradycardia Syncope Patients wearing a Medtronic market-released device or treated by a Medtronic therapy who have signed a patient data release and informed consent form Patients unwilling or unable to cooperate or give voluntary consent
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Unstable Angina Acute Myocardial Infarction Congestive Heart Failure Age equal to or greater than 18 years at time of consent Written informed consent Patients admitted to the intensive care unit if able to remove oxygen Patients admitted to telemetry and step-down floor that will not require oxygen Primary diagnosis (any of the following) Un-stable angina Acute myocardial infarction Congestive heart failure Previously diagnosed sleep disordered breathing Inability to consent Pregnancy Intubation (no longer excluded after extubation) Oxygen therapy (no longer excluded after therapy ends) End-Stage renal disease End-Stage liver disease Terminal disorders other than cardiac Severe scoliosis Cervical spinal cord injuries
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Sudden Cardiac Death Ventricular Tachycardia Ventricular Fibrillation Cardiomyopathy Appropriate ICD shock for VT after at least one catheter ablation of VT procedure, OR appropriate ICD shock for VT but not a candidate for catheter ablation of VT (i.e. patients with presence polymorphic VT or ventricular fibrillation, LV thrombus, VT arising from an inaccessible myocardial location). 2. Presence of structural heart disease as defined as EF ≤ 50%, presence of ventricular scar as detected by imaging modalities or electroanatomic mapping, hypertrophic cardiomyopathy, cardiac sarcoidosis, or arrhythmogenic right ventricular cardiomyopathy. 3. Patient is taking at least one anti-arrhythmic drug or has documented intolerance or toxicity to at least one anti-arrhythmic drug. 4. Age greater than 18 years old. 5. Able and willing to comply with all pre and follow-up testing and requirements. 6. Provision of signed informed consent and stated willingness to comply with all study procedures for duration of the study Active ongoing cardiac ischemia as assessed by: ECG, cardiac enzymes, symptoms, coronary angiography with evidence of significant epicardial coronary stenosis (>70%), or stress testing. (Note: positive troponin assay due to ICD shocks is not an criterion). 2. Any medical or non-medical condition likely to prevent completion of trial. 3. Contraindication to cardiac sympathetic denervation (i.e. unlikely to tolerate general anesthesia, single-lung ventilation, severe pulmonary disease, or severe pulmonary hypertension) or previous cardiac sympathetic denervation procedure. 4. Left ventricular assist device or status post orthotopic heart transplantation 5. Severe thrombocytopenia (platelets < 50,000) or coagulopathy (INR > 2.0) that is not due to medications or a reversible cause. 6. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal). 7. Unable or unwilling to comply with protocol requirements. 8. NYHA class IV heart failure symptoms. 9. Known channelopathy such as long QT syndrome and catecholaminergic polymorphic VT. 10. Presentation with slow VT (VT rate < 150 bpm)
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-55.0, Musculoskeletal Pain Signed and dated informed consent prior to participation Subjects in good health as determined by the Investigator Age 18-55 Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit) For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation Participation in another clinical study within the last 30 days and during the study Subjects who are inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Pregnancy or lactation Alcohol or drug abuse Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma Skin lesions, dermatological diseases or tattoo in the treatment areas Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose Varicosis, thrombophlebitis and other vascular disorders of the lower extremities Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal system of the lower limbs
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, HIV Infection Liver Failure Evidence of Liver Transplantation Age ≥ 18 Documented HIV-1 infection, hepatitis B or C co-infection is allowed Plasma viral load at screening visit below 50 copies per mL for at least 6 months Patient with severe liver failure (Meld Score ≥ 15 and/or refractory ascites and/or haemorrhage of digestive tract and/or hepatic encephalopathy) for taking part into period 1 Patient eligible for the liver transplant waiting list or immediate post transplantation for taking part into period 2 Abstinence from alcohol intake for at least 6 months (WHO norm) Withdrawal from intravenous drug use for at least 6 months (methadone substitution is permitted) No ongoing class C opportunistic infection (1993 CDC classification) Patient whose clinical and immunovirological condition allows triple therapy with raltegravir + 2 NRTI or raltegravir + NRTI + enfuvirtide Patient whose HIV population, according to cumulative genotypes carried out on viral RNA together with treatment history (if available and interpreted as per the ANRS-AC11 algorithm version no.19) does not present a profile of mutations associated with resistance to raltegravir and is sensitive to at least two fully active* agents selected among nucleoside/nucleotide reverse transcriptase analogs NRTI (abacavir, lamivudine, emtricitabine, tenofovir) or enfuvirtide *An ARV agent is considered to be fully active if the cumulative genotypes do not show any mutation associated with resistance or any mutation associated with "possible resistance" More than two virological failures during antiretroviral treatment Currently receiving treatment with an agent in development (apart from an authorization for temporary use) Plasma viral load at screening visit ≥ 50 copies per mL during at least the last 6 months Pregnant women, or women liable to become pregnant, breast-feeding women, no contraception, or refusal to use contraception All conditions (including but not limited to alcohol intake and drug use) liable to compromise, in the investigator's opinion, the safety of treatment and/or the patient's compliance with the protocol Patient not having any effective options for NRTI +/ enfuvirtide (defined in the criteria) Ongoing treatment with interferon-alpha or ribavirin for hepatitis C Concomitant medication including one or more agents liable to induce UGT1A1 and reduce raltegravir concentrations anti-infective agents: rifampicin/rifampin
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 0.5-999.0, HIV Infection Rheumatic Disease Cancer Transplant Pediatrics medically recommended influenza A(H1N1) immunization signed informed consent failure or refusal to provide sufficient blood for antibody determination
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-59.0, First Episode Psychosis Aged 18-59 years and meet DSM-IV diagnostic for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version Meeting DSM-IV for another axis I diagnosis, including substance abuse or dependence Needing another nonantipsychotic psychotropic medication at enrollment Having a serious or unstable medical illness Pregnant or lactating women or women without adequate contraception will be also excluded
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Metastatic Melanoma ENTRY Locally advanced or metastatic melanoma Measurable Histologically or cytologically confirmed Surgically incurable HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT If prior Proleukin treatment, must have had clinical benefit No prior systemic cytotoxic chemotherapy for melanoma No concurrent radiotherapy, chemotherapy, or other immunotherapy More than 4 weeks since prior major radiotherapy
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 0.0-999.0, Cardiac Output Blood Pressure Medical patients without complex medical history with expected hospital stay for less than 10 days Uncomplicated Medical Patients as define as (1) Previously healthy children or (2) Children with diagnosis of a single chronic medical disorder that is not associated with cardiac dysfunction Congenital heart disease with and without repair (includes PFO, ASD and PDA, cardiac valve disease or pulmonary hypertension Chronic lung disease (except asthma) Abnormal Hemoglobin (SSD)
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-80.0, Ventricular Tachycardia Age 18 years or above, documented coronary heart disease, myocardial scar tissue verified by CMR, implanted ICD Planned revascularisation by bypass surgery or percutaneous coronary intervention following the ICD implantation, planned arrhythmia ablation, long QT-syndrome, Brugada syndrome, WPW syndrome, Drug-induced torsades, catecholaminergic polymorphic ventricular tachycardia, Hypertrophic cardiomyopathy right ventricular cardiomyopathy, dilated cardiomyopathy, Aortic stenosis, mitral valve prolapse, anomalous origin of coronary arteries, Myocardial bridging, ongoing myocarditis, recent chest trauma
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-75.0, Ventricular Tachycardia Previous Myocardial infarction Symptomatic, drug-refractory and haemodynamically stable VT following CAD Undergoing a VT ablation Implanted ICD Documented valvular heart disease Acute myocardial infarction within the preceding 1 month Unstable angina Prolonged QT interval Patients with hemorrhagic or thrombophilic disorders Documented intra-atrial thrombus, tumor or other conditions which prevent easy catheter introduction
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 19.0-999.0, Pacemaker Patient has a current indication for a single-chamber (SR) or dual-chamber (DR) pacemaker or CRT-P device Patient is implanted with an SJM Accent™ SR/DR, Accent™ SR/DR RF, Anthem™ CRT-P, Anthem™ CRT-P RF, or newer SJM pacemaker device Patient is geographically stable and willing to comply with the required follow-up schedule Patient is not pregnant or planning to become pregnant Patient is >18 years of age Patient's life expectancy is less than 12 months
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Infection Osteoarthritis of the Knee patients with osteoarthritis of the knee patients who are undergoing primary knee replacement patients who are able to provide informed consent patients with a prior joint infection patients who have a known allergy to tobramycin, and patients who have no fixed address
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 40.0-75.0, Acute Coronary Syndrome Myocardial Infarction Unstable Angina Pectoris Participant had at least five minutes of chest pain or equivalent (chest tightness; pain radiating to left, right, or both arms or shoulders, back, neck, epigastrium, jaw/throat; or unexplained shortness of breath, syncope/presyncope, generalized weakness, nausea, or vomiting thought to be of cardiac origin) at rest or during exercise within 24 hours of ED presentation, warranting further risk stratification, as determined by an ED attending. 2. 2 or more cardiac risk factors (diabetes, hypertension, hyperlipidemia, current smoker and family history of coronary artery disease). 3. Able to provide a written informed consent. 4. <75 years of age, but >40 years of age. 5. Able to hold breath for at least 10 seconds. 6. Sinus rhythm New diagnostic ischemic ECG changes (ST-segment elevation or depression > 1 mm or T-wave inversion > 4 mm) in more than two anatomically adjacent leads or left bundle branch block 2. Documented or self-reported history of CAD (MI, percutaneous coronary interventions [PCIs], coronary artery bypass graft [CABG], known significant coronary stenosis [>50%]) 3. Greater than 6 hours since presentation to ED. 4. BMI >40 kg/m2 5. Impaired renal function as defined by serum creatinine >1.5 mg/dL* 6. Elevated troponin-T (> 0.09 ng/ml) 7. Hemodynamically or clinically unstable condition (BP systolic < 80 mm Hg, atrial or ventricular arrhythmias, persistent chest pain despite adequate therapy) 8. Known allergy to iodinated contrast agent 9. Currently symptomatic asthma 10. Documented or self-reported cocaine use within the past 48 hours (acute) 11. On Metformin therapy and unable or unwilling to discontinue for 48 hours after the CT scan 12. Contraindication to beta blockers (taking daily antiasthmatic medication): This only applies to patients with a heart rate >65 bpm at sites using a non-dual source CT scanner 13. Participant with no telephone or cell phone numbers or no address (preventing follow-up) 14. Participant with positive pregnancy test. Women of childbearing potential, defined as <2 years of menopause in the absence of hysterectomy or tube ligation, must have a pregnancy test performed within 24 hours before the CT scan. 15. Participant unwilling to provide a written informed consent
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1
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-80.0, Atrial Fibrillation Radiofrequency Ablation Patients undergoing clinically indicated pulmonary vein ablation for atrial fibrillation Unable to understand consent form. Not scheduled for clinically indicated pulmonary vein ablation
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 19.0-84.0, Defibrillators, Implantable Tachycardia, Ventricular Patients must meet all of the following > 18 and < 85 years of age ICD implanted for primary prophylaxis against sudden cardiac death or ICD implanted for secondary prophylaxis against spontaneous or inducible sustained VT without any reversible causes Coronary artery disease (CAD) with prior myocardial infarction (MI) ICD or electrocardiogram (ECG) documentation of ventricular arrhythmia responsible for appropriate ICD therapy [antitachycardia pacing (ATP) & shocks] Patients should not have any of the following Contraindication or allergy to contrast media, routine procedural medications or catheter materials Contraindication to an interventional procedure Current or previous (within 3 months) amiodarone therapy Atrial Fibrillation requiring antiarrhythmic drug therapy Contraindication to amiodarone therapy New York Heart Association (NYHA) functional class IV Myocardial infarction within the past 60 days Stroke within the past 90 days Unstable angina
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Coronary Artery Disease Left Ventricular Dysfunction Sudden Cardiac Death Evidence of Coronary Artery Disease (CAD) a or documented prior Myocardial Infarction. 2. LVEF >35% by any current standard evaluation technique (e.g.,) echocardiogram, MUGA, angiography). 2.1. Patients who have an LVEF between 30-35% and NYHA Class I heart failure who do not have history of ventricular tachyarrhythmias,or inducible ventricular tachycardia during electrophysiological (EP) testing can be enrolled. 3. If documented prior MI is not present, evidence of mild-moderate systolic Left Ventricular Dysfunction with an EF >35 ≤50% as measured by any current standard screening technique (e.g.,echocardiogram, MUGA, angiography) must be present. 4. Patients aged 18 years or above 1. CAD will be defined as evidence of one of the following two (2) Significant stenosis of a major epicardial vessel (>50% proximal or 70% distal) by coronary angiography Prior revascularization (percutaneous coronary intervention or coronary artery bypass surgery) 2. MI can be documented in the following ways From the MI hospitalization: Detection of a rise and fall of cardiac biomarkers > 99th percentile of lab (e.g., CPK elevation or Troponin at least > two times the upper limit of normal) together with myocardial ischemia with at least one of the following Symptoms of Ischemia ECG changes indicative of new ischemia (new ST-T changes or new LBBB) Development of pathological Q waves Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality If no report from the MI hospitalization is available, prior MI can be met by either of the following History of cardiac arrest or spontaneous or inducible sustained VT (15 beats or more at a rate of 120 BPM or greater the occurrence of cardiac arrest or spontaneous VT in the setting of an acute MI is not considered an exclusion). 2. Unexplained syncope 3. Current or planned implantable cardiac defibrillator (ICD) 4. Any condition other than cardiac disease that, in the investigator's judgment, would seriously limit life expectancy (poor survival) 5. Metastatic cancer 6. Marked valvular heart disease requiring surgical intervention 7. Current or planned cardiac, renal or liver transplant 8. Current alcohol or drug abuse 9. Unwilling or unable to provide informed consent 10. LVEF <35% with Class II-IV CHF or LVEF <30% 11. Participation in a clinical trial where the active treatment arm is testing an agent and/or intervention with known antiarrhythmic properties
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1
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Prostate Adenocarcinoma Recurrent Prostate Carcinoma Stage IV Prostate Cancer All patients must have a histologically or cytologically proven diagnosis of adenocarcinoma of the prostate; note: If there is no formal biopsy report documenting the diagnosis of prostate cancer, the patient can be allowed on trial if the PSA level is at least 20, and there are at least three definitive metastatic lesions seen on scan; all patients must have had metastatic (M1) disease as evidenced by soft tissue and/or bony metastases prior to androgen deprivation therapy initiation; patients must have at least one of the following at the time they started androgen deprivation therapy Visceral disease (liver, lung, or other viscera) Bone metastases to sites in either the axial (spine, pelvis, ribs, or skull) and/or the appendicular (clavicle, humerus, or femur) skeleton Lymph node disease not considered to be encompassed within a single radiotherapy port (e.g., above the aortic bifurcation, etc.) Patients who have measurable disease must have radiographic assessment (at least an abdominal/pelvic computed tomography [CT]) within 28 days prior to registration; non-measurable disease must also be assessed (e.g., bone scan) in all patients within 56 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form Patients must have a PSA >= 5 ng/mL obtained within 90 days prior to initiation of androgen deprivation therapy Patients with known brain metastases are not eligible; brain imaging studies are not required for if the patient has no neurologic signs or symptoms, but if brain imaging studies are performed, they must be negative for disease Patient must have had no more than 30 days of prior medical castration for metastatic prostate cancer (prior androgen deprivation therapy is allowed if it was received with curative intent in the neoadjuvant, concurrent, and/or adjuvant fashion and at least 2 years have elapsed since completion of androgen deprivation therapy); the start date of medical castration is considered the day the patient first received an injection of a LHRH agonist, not an oral antiandrogen; if the method of castration is luteinizing hormone releasing hormone (LHRH) agonists (i.e., leuprolide or goserelin), the patient must be willing to continue the use of LHRH agonists and add bicalutamide for combined androgen deprivation therapy (ADT) during protocol treatment; the 30 day window begins from the date of receiving the LHRH agonist, not the oral antiandrogen; if the patient was on a different antiandrogen (e.g. flutamide), the patient must be willing to switch over to bicalutamide; patients must not have received bilateral orchiectomy; patients must not have received or be planning to receive LHRH antagonists (i.e., Degarelix); however, if the patient was initiated on a LHRH antagonist within the 30 day window and is willing to switch to a LHRH agonist with bicalutamide, he may enroll on the late induction group Patients who have not already started androgen deprivation therapy must be offered the opportunity to participate in the translational medicine studies; once a patient has started any form of antiandrogen (i.e., either bicalutamide or LHRH agonist), he is not eligible for any translational medicine studies Patients must not have received any prior cytotoxic chemotherapy for metastatic prostate cancer; prior cytotoxic chemotherapy with curative intent in the neoadjuvant or adjuvant setting is allowed; patients must not have received any prior treatment with agents that directly inhibit IGF or IGFRs
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-75.0, Heart Failure at NYHA Stage III or IV Non Responders to Resynchronization Non Candidates for Transplantation patients with heart failure class III or IV NYHA LVEF < 35% resynchronization for at least 6 months non for cardiac transplant operability and psychological assessed Patients incapable of understanding the proposed procedure, its risks and potential benefits or the consequences engendered by the permanent implanting of a left ventricular assist device Patients on mechanical circulatory support, including an intra-aortic counter-pulsion balloon, at the time of randomisation Patients with acute decompensated cardiac insufficiency at the time of randomisation Patients whose body surface area is below 1.2m² Patients with a mechanical cardiac valve Patients requiring associated aortic or mitral surgery Patients with an active uncontrolled infection Patients with a severe pulmonary respiratory pathology Patients with contra-indications for or an intolerance to anti-coagulants or platelet anti-aggregants Presence of risk factors or indicators of visceral failure (severe COPD, renal insufficiency with dialysis, hepatic insufficiency with cholestasis…)
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Atrial Fibrillation Atrial Flutter ED patients 18 years and older Provide informed consent Have a documented diagnosis of AF or atrial flutter on electrocardiogram or rhythm strip from an ED, prehospital provider or outside medical facility on day of enrollment Present with signs (tachycardia, dyspnea) or symptoms (palpitations, chest pain, shortness of breath, weakness, lightheadedness, pre-syncope, or syncope) consistent with primary symptomatic AF Patients whose primary complaint is not directly related to their AF diagnosis (e.g. evaluation for febrile illness, gastrointestinal complaint, injury) BUT have a secondary complaint consistent with symptomatic AF that requires ED evaluation (e.g. new AF diagnosis, AF associated with inadequate rate control (defined as resting heart rate greater than 100bon), AF associated with heart failure symptoms, AF in the setting of CVA or TIA, AF associated with other thromboembolic complications) Patients who are under the age of 18 Previously enrolled patients ED patients who present with complaints unrelated to their AF (e.g. sprained ankle,pharyngitis) and have adequately rate (<100 bpm at rest) or rhythm controlled-AF
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Atrial Fibrillation Screening Persistent AF for more than 72 hours (documented by an ECG taken within the last 72 hours) for whom cardioversion, anti-arrhythmic treatment and anticoagulation treatment are indicated in the opinion of the Investigator Naive of amiodarone treatment in the last three months QTc Bazett < 500 ms on 12-lead ECG At least one cardiovascular risk factor (i.e. age > 70, hypertension, diabetes, prior cerebrovascular disease or left atrial diameter >= 50 mm Randomization Outpatient and Inpatients (except patients hospitalized during screening period for SAE) Sinus rhythm Effective oral anticoagulation verified by International Normalized Ratio/INR (target > 2) QTc Bazett < 500 ms and PR < 280 ms on 12-lead ECG Completed treatment period with amiodarone (28 days ± 2 days) Screening Contraindication to oral anticoagulation Acute condition known to cause AF Permanent AF Paroxysmal AF Bradycardia < 50 bpm on the 12-lead ECG Clinically overt congestive heart failure with New York Heart Association (NYHA) classes III and IV heart failure with LVEF < 35% or NYHA class II with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 6.0-12.0, Attention-deficit/Hyperactivity Disorder Diagnosis of ADHD-inattentive or combined type Intelligence (IQ) below 85 as determined by formal testing Identified or suspected genetic syndromes Autism or other pervasive developmental disorders Psychiatric disorders other than ADHD and oppositional defiant disorder Heart, liver or renal disease Cancer Epilepsy or non-febrile seizure history Cardiac arrhythmia, bradycardia, or syncope Any other condition considered to be potentially exacerbated or endangered by treatment with an alpha-2 agonist drug
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-80.0, Coronary Artery Disease Age 18-80 years old Canadian cardiovascular (CV) Class II-IV angina and/or NYHA class II-III HF symptoms Received stable and "best" cardiac medical therapy including long-acting nitrates, beta-blocker, and angiotensin-converting enzyme inhibitors without control of symptoms Not suitable for conventional revascularization by their referring cardiologist LVEF <40% by echocardiography Recent coronary angiogram (within the last 6 months) to document the coronary anatomy and insure the presence of CAD that is not amenable to standard revascularization procedures creatinine less than 250mmol/L, normal liver function, and normal blood count: WBC, granulocytes; platelet count, Hb Reversible perfusion defect on single photon emission computed tomography (SPECT) Able to walk on treadmill Hemodynamically stable Atrial fibrillation History of syncope or major ventricular arrhythmias such as sustained ventricular tachycardia or ventricular fibrillation Severe valve disease Aortic or mitral valve prosthesis History of cancer in last 5 years Acute or chronic active sepsis, including HIV positive; hepatitis B or C positive Left ventricular wall thickness less than 8 mm in the target territory Left ventricular thrombus and/or spontaneous echo-contrast in the LV detected by echocardiography or LV aneurysm Severe aorto-femoral-iliac disease Recent heart attack within the last 30 days
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-75.0, Androgen Deficiency AD Erectile Dysfunction ED Diabetes Mellitus Coronary Artery Disease Coronary Revascularization Male age [18-75 years] Type 2 Diabetes, defined according to the American Diabetes Association as history of: a) presence of classic symptoms of DM with unequivocal elevation of plasma glucose (2-hour post-prandial or random of >200 mg/dL (11mmol/L), b) fasting plasma glucose elevation on more than 1 occasion of at least 126 mg/dL (7mmol/L) or c) HA1C > 6.5, currently undergoing pharmacological or non-pharmacological treatment Angiographically confirmed Coronary Artery Disease (≥50%) with or without PCI Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischemia Willingness to comply with all follow-up required study visits; and Signed and received copy of informed consent Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema) at the time of enrollment Previous stroke within 6 months Prior history of significant bleeding (within the previous 6 months) that might be expected to occur during PCI/DES related anticoagulation Acute ST-elevation MI (Q-wave) within 72 hours prior to enrollment requiring revascularization Abnormal creatine kinase (CK > 2x normal); or abnormal CK-MB levels at time of randomization Contraindication to either CABG or PCI/DES because of a coexisting clinical condition] Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis Intolerance or contraindication to aspirin or both clopidogrel and ticlopidine Dementia with a Mini Mental Status Examination (MMSE) score of <20 Extra-cardiac illness that is expected to limit survival to less than 5 years (e.g. oxygen-dependent chronic obstructive pulmonary disease, active hepatitis or significant hepatic failure, severe renal disease)
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Left Ventricular Hypertrophy All patients over 18 years undergoing a routine echocardiography in the participating hospitals Both genders will be considered Patients can be included if on 2D echocardiography the maximal septal wall thickness > 13 mm and/or the posterior wall thickness > 13 mm. The limit for is kept relatively low to detect early forms of Fabry cardiomyopathy
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-45.0, Pain The patient is aged > 18 years The patient is in early labour ≤ 5cm cervical dilatation The patient is American Association of Anaesthesiologists Grade I The patient provides written informed consent to participate in the trial prior to surgery The patient has any known chronic medical condition for which regular medication is required The patient has received any investigational drug within the 90 days prior to the study or is scheduled to receive one during the study period The patient is scheduled for caesarean section The patient has received opioids in the last 4 hours The patient has evidence of alcohol or drug abuse There is evidence of obstetric complications The fetus has shown signs of intrauterine growth retardation The patient has findings on pre-study evaluations (e.g. laboratory results, medical history, physical examination, ECG) that are clinically significant in the investigator's opinion such to entry into the study
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 40.0-80.0, Prostate Cancer Cancer Population: 1. Diagnosis of prostate cancer 2. Treatment group: Scheduled to start AST, at Ottawa Hospital under the care of Radiation Oncology, Urology or Medical Oncology. Control group: no AST scheduled as a treatment option for prostate cancer. Non-Cancer Control Group 1. Male with low pre-test likelihood of coronary artery disease 2. No previous history of cancer Known coronary disease including any of previous revascularization, history of myocardial infarction, coronary disease with >= 50% stenosis in a major coronary vessel on previous angiography, evidence of previous myocardial infarction on 12-lead electrocardiogram, positive myocardial perfusion scan, previous cardiac PET scan, stress echocardiogram or exercise stress test. 2. Subjects with a Summed Stress Score of >4 attributed to coronary disease on baseline PET images 3. Patients previously treated with AST 4. Patients with a life expectancy of less than 1 year
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Ventricular Tachycardia Arrhythmia Patients with ventricular arrhythmias requiring VT Ablation Patients must be 18 years of age or older Patient must be able to sign consent form Patient must be willing to come back for the 6 month visit for additional study procedures Patient under 18 years old Inability to sign consent Pregnant Women
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Recurrent Prostate Carcinoma Stage I Prostate Cancer AJCC v7 Stage IIA Prostate Cancer AJCC v7 Stage IIB Prostate Cancer AJCC v7 Stage III Prostate Cancer AJCC v7 Patient must have histologically confirmed diagnosis of prostate cancer Patient must have had previous treatment with definitive surgery or radiation therapy or cryoablation Patient may have prior salvage therapy (surgery, radiation or other local ablative procedures) within 4 weeks prior to randomization if the intent was for cure; prophylactic radiotherapy to prevent gynecomastia within 4 weeks prior to randomization is allowed Patient must have no evidence of metastatic disease on physical exam, computed tomography (CT) abdomen/pelvis (or magnetic resonance imaging [MRI]), chest x-ray (or CT chest) and bone scan within 8 weeks prior to randomization Patient may have had prior neoadjuvant and/or adjuvant therapy (chemotherapy, vaccines or experimental agents) within 4 weeks prior to randomization, if the PSA rise and PSA doubling time (PSADT) were documented after the testosterone level was > 150 ng/dL Patient may not have had therapy modulating testosterone levels (such as luteinizing-hormone, releasing-hormone agonists/antagonists and antiandrogens) within 1 year prior to randomization, unless it was in the neoadjuvant and/or adjuvant setting; agents such as 5 alpha reductase inhibitors, ketoconazole, abiraterone, systemic steroids, or herbal supplements known to decrease PSA levels including any dose of megestrol acetate, finasteride (e.g., Saw Palmetto and PC-SPES, African pygeum extract, lycopene, alanine, glutamic acid and glycine, beta-sitosterol, lycopene, nettle root extract, quercitin, Belizian Man Vine extract, mulra puama extract and epimedium extract campesterol, beta-sitosterol, stigmasterol, sitostanol and brassicasterol) are not permitted at any time during the period that the PSA values are being collected Patient must have hormone-sensitive prostate cancer as evident by a serum total testosterone level > 150 ng/dL within 12 weeks prior to randomization Patient must have evidence of biochemical failure after primary therapy and subsequent progression Biochemical failure is declared when the PSA reaches a threshold value after primary treatment and it differs for radical prostatectomy or radiation therapy For radical prostatectomy the threshold for this study is PSA >= 0.4 ng/mL
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 45.0-80.0, Hemodialysis Cardiac Arrhythmia Cardiac Death Patients under chronic hemodialysis Age between 45 and 80 yo written informed consent affiliated to the French Social Security system Pace-maker or Implantable Cardioverter Defibrillator Active infection Neoplasia or any pathology with a life expectancy <12 months Cachexia Patient with restricted civic rights by law
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 22.0-999.0, Post-Operative Cancer Patients Experiencing Atrial Fibrillation Post-Operative cancer patients experiencing atrial fibrillation and otherwise clinically ready to be discharged Must attend two outpatient visits at MSKCC's cardiology practice during the study period, as specified by the participant's Attending Must be older than 21 years of age Non-English speaking patients
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 60.0-999.0, Level of Pain Above 60 years of age Letter of approval firmed Proximal femur fracture Pathologic fracture History of metabolic bone disease Earlier surgery s of the hip or femur on the same leg Fractures with osteosynthesis material of earlier treatment still in place Soft tissue damage Delay of surgery for more than 3 days Immune default Polytrauma Fracture ends more than 5 cm distal of trochanter minor
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-75.0, Coronary Artery Disease ≤ 75 years of age stable coronary artery disease preserved left ventricular function physical work capacity of ≥ 50 successful elective percutaneous coronary intervention at study begin diabetes mellitus hypercholesterolemia untreated hypertension smoking myocardial infarction within the last 4 weeks significant stenosis of the left main coronary artery
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Acute Myocardial Infarction Coronary Artery Disease Adults ≥ 18 years of age Chest pain for < 12 hours ST-elevation Myocardial Infarction including either: 1) Persistent ST-segment elevation of ≥1mm in two contiguous limb leads; 2) ST-segment elevation of ≥ 2mm in two contiguous chest leads, or; 3) New left bundle branch block (LBBB) pattern Able to be transported to a participating hospital Hypoxia with oxygen saturation measured on pulse oximeter < 94% with the patient breathing air Bronchospasm requiring nebulised salbutamol therapy using oxygen Altered conscious state
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Ventricular Arrhythmias Patients 18 years and older Patients with class I or IIa indication for ICD therapy according to the ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death Patients with documented therapy refractory monomorphic ventricular tachycardia Patients having an indication for pacing therapy Patients with ventricular tachycardia less than 170 bpm Patients failing appropriate QRS/T-wave sensing with the S-ICD ECG patient screening tool provided by Cameron Health/Boston Scientific Patients with incessant ventricular tachycardia Patients with a serious known concomitant disease with a life expectancy of less than one year Patients with circumstances that prevent follow-up (no permanent home or address, transient, etc.) Patients who have had a previous ICD implant Patient who receive cardiac contractility modulation therapy or are likely to receive cardiac contractility modulation therapy Patients who are unable to give informed consent
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 0.0-999.0, Acute Coronary Syndrome Heart Failure Arrhythmia All Patients visiting the ER between Jan 2009 and Dec 2010 at the Rambam Medical Center in Haifa Israel There are no
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-85.0, High Heart Rate Dialysis patients Sinus rhythm Pre-dialytic Heart rate > 80 bpm Atrial fibrillation/atrial flutter Heart failure Valvular disease
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Syncope Pre-syncope Atrial Fibrillation Supraventricular Tachycardia Syncope of uncertain etiology or Pre-syncope of uncertain etiology or Palpitations of uncertain etiology or Management of known AF/SVT patients Any abnormal or friable skin over the anterior thorax and upper abdomen Sternal incision within 3 months from the date of enrollment
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Cardiac Arrhythmia Any patient undergoing ablation
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 0.0-999.0, Cardiovascular Events All patients who has experienced cardiovascular events Patients with no cardiovascular events
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 20.0-80.0, Arrhythmia male or postmenopausal female, aged 20 to 80 years inclusive clinical indication for catheter ablation of atrial flutter history of paroxysmal atrial flutter, with or without paroxysmal AF. Single episodes of persistent atrial flutter or AF requiring cardioversion do not the patient from the study sinus rhythm at randomisation adequate anticoagulation or antithrombotic treatment according to ESC guidelines 2010 or national guideline cardioversion within 14 days before randomisation history of stroke or transient ischaemic attack (TIA). History of significant head trauma, epilepsy or other disorders increasing the risk for seizures QTcF >450 ms or <350 ms measured in sinus rhythm at randomisation history and/or signs of clinically significant sinus node dysfunction. Sinus bradycardia (50 beats per minute or less) at randomisation personal or family history of Torsades de Pointes (TdP), any other polymorphic ventricular tachycardia, long QT syndrome, short QT syndrome, Brugada syndrome, or personal history of sustained (>30 s) monomorphic ventricular tachycardia
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Ischemic Cardiomyopathy Hibernating Myocardium Nerve; Disorder, Sympathetic LV EF ≤35% (by nuclear imaging, cardiac catheterization or echocardiography) Coronary artery disease documented by cardiac catheterization, a history of definite myocardial infarction, or reversible ischemia on nuclear imaging New York State Heart Association functional Class I-III heart failure Not a candidate for surgical or percutaneous coronary revascularization at the time of enrollment History of resuscitated sudden cardiac death, sustained ventricular tachycardia, appropriate implantable cardiac defibrillator (ICD) discharge, or unexplained syncope Myocardial infarction within 30 days Coronary artery bypass grafting within 1 year Percutaneous intervention within 3 months Claustrophobia or physical limitation that would preclude PET scanning Pregnancy Tricyclic antidepressant drug therapy Comorbidities that would be expected to result in noncardiac death within 2 years Inability to provide informed consent
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, CAD Patients on a simultaneous ASA, NSAID treatment > 18 years unconsciousness, not able to consent reanimation, cardiac shock
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 45.0-85.0, CAD Able and willing to provide informed consent Women at least 45 years old of any race Taking 81 mg aspirin daily, for at least one month Diagnosed with known or suspected CAD with at least one of the following: angiographic evidence of at least one lesion > 50% stenosis, history of significant elevation of biomarker troponin or CK-MB, or history of ECG changes in at least 2 contiguous leads characterized by either new ST depression > 0.1 mV or transient (<30 min) ST elevation > 0.1 mV, coronary artery revascularization either by PCI or CABG < 45 years or > 85 years of age Clinically unstable: hypotension defined as sustained systolic blood pressure of <90 mmHg due to cardiac failure with associated symptoms, unstable or severe pulmonary edema, decompensated congestive heart failure, acute mitral regurgitation, acute ventricular septal defect, acute cerebrovascular event or transient ischemic attack (TIA) within the past six months, history of ventricular fibrillation and no implantable cardioverter defibrillator (ICD), sustained supraventricular tachycardia > 30 seconds or associated with symptoms and no ICD, untreated complete heart block or untreated high grade secondary heart block Pregnant, planning to become pregnant, or breastfeeding Alcohol abuse or illicit drug abuse Allergy or intolerance to salicylates and/or excipients including a history of and/or active GI bleed Use of NSAIDs within seven days or planned regular use during the study Taking HRT or oral contraceptives within the past 30 days or planned use during study Use of heparin, warfarin, ADP inhibitors (clopidogrel, prasugrel, or ticlopidine), or glycoprotein IIb/IIa inhibitors within previous 96 hours or planned use during the study Use or planned use of any other medications known to interfere with AA-induced platelet function Currently participating in another investigational drug or device study
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Prostatic Neoplasms Patients must have histopathological documentation of prostate cancer prior to starting this study. Patients must have metastatic progressive castrate-resistant prostate cancer defined as progressive disease (see below) despite surgical castration or ongoing use of gonadotropin-releasing hormone agonists with confirmed castrate levels of testosterone. of progression for trial are defined from the Prostate Cancer Clinical Trials Working Group-253. Clinically progressive prostate cancer must be evidenced and documented by any of the following parameters: 1. Two consecutively rising PSA values at a minimum of 1-week intervals (2.0 ng/mL is the minimum starting value for PSA) 2. Appearance of one or more new lesions on bone scans 3. Progressive measurable disease by 1.1 Patients on flutamide for at least 6 months must have disease progression at least 4 weeks after withdrawal. Patients on bicalutamide or nilutamide for at least 6 months must have progression at least 6 weeks after withdrawal.2.1.1.4 Performance Status: ECOG 0-1 or Karnofsky 80-100% (asymptomatic or minimally symptomatic from metastatic disease). No previous chemotherapy use. No therapeutic immunosuppression or immunomodulation altering bone marrow function within 6 weeks prior to study entry e.g. G-CSF, GM-CSF, EPO, prednisone etc. Must have adequate Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl. Platelets greater than or equal to 100,000/mcl Renal function: Creatinine less than or equal to 1.5 times institutional upper limit normal (ULN) Hepatic function: Bilirubin less than or equal to 1.5 x ULN (CTCAE v4.0 grade 1) except patients with Gilbert's disease (up to 5.0 mg/dL). SGOT and alkaline phosphatase less than or equal to 2.5 x ULN Normal Cardiac function: ECG with no evidence of arrhythmia, conduction abnormality or ischemia. No active coronary artery disease; no New York Heart Association class II, III or IV disease; no arrhythmia requiring treatment. Must willing and able to sign an informed consent document that explains the neoplastic nature of the disease, the procedures to be followed, the experimental nature of the treatment, alternative treatment and potential risks and toxicities Concurrent treatment with any other cancer therapies including radiation (except palliative radiation therapy for bone metastases), chemotherapy or other investigational agent(s). Androgen suppression therapy will be allowed. History of a second active malignancy in the last 2 years other than non-melanoma skin cancers. Patients who have active or history of autoimmune disease/symptom/conditions including: type I diabetes, rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), ankylosing spondylitis. Type II diabetes mellitus, vitiligo or stable hypothyroidism are not considered Patients being chronically treated with immunosuppressive drugs such as cyclosporin, adrenocorticotropic hormone (ACTH). Concurrent use of systemic glucocorticoids within 4 weeks prior to trial entry Patients who have acquired, hereditary, or congenital immunodeficiencies including cellular immunodeficiencies, hypogammaglobulinemia and dysgammaglobulinemia. CNS, lung, or liver metastasis, because of the poor prognosis, and potential inability to meet study endpoints. Serious active infection at the time of pre-study screening. Positive HIV or Hepatitis C antibodies or Hepatitis B anti-core antibodies, because immunotherapies rely on intact immune systems, and toxicities may be exacerbated by the presence of infection
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 0.0-999.0, Syncope Heart Block Conduction Disorder of the Heart -Patients are eligible if they have >1 syncopal spell within 1 year preceding enrollment, and bifascicular block on a 12-lead ECG, and Age > 50 years and written informed consent. Syncope will be defined based on history using a standardized form -Patients will be excluded if they have related to study strategies, including: 1. previous pacemaker, ICD, or Implantable Loop Recorder in situ, 2. ACC/AHA/HRS Class I indication for permanent pacing or ICD implantation, 3. left ventricular ejection fraction < 35% mandating ICD therapy, 4. contra-indication to a transvenous pacemaker such as artificial tricuspid valve or active sepsis. -Patients will also be excluded if a potential competing cause of syncope poses a threat to life, such as: 5. hypertrophic cardiomyopathy, 6. documented sustained ventricular tachycardia or 7. inducible, sustained monomorphic ventricular tachycardia on EP study. -They will be excluded if they have: 8. a history of myocardial infarction within 3 months prior to enrollment, and 9. a major chronic co-morbid medical condition that would preclude 24 months of follow-up
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-75.0, Chronic Kidney Disease Secondary Hyperparathyroidism Adults (ages 18 years) 2. A diagnosis of chronic kidney disease (CKD) with a glomerular filtration rate (GFR) in the range of 20 ml/min/1.73 m2. 3. Proteinuria confirmed at least twice by one of the following (at least one sample within the last 6 months) hour urine protein excretion of at least 150 mg/day OR spot urine protein to creatinine ratio (PCR) of greater than 0.15 OR spot urine albumin to creatinine ratio (ACR) greater than 100 mg/g 4. A recent diagnosis of secondary hyperparathyroidism of renal origin by the patient's nephrologist scheduled for treatment with an active from of vitamin D. 5. Available results for serum intact parathyroid hormone (iPTH), calcium and phosphorus within 6 months from the study enrollment date. 6. Treatment with a stable dose of an angiotensin receptor blocker (ARB), angiotensin converting enzyme inhibitor (ACE-I) or rennin inhibitor within the last 2 months before enrollment in the study GFR less than 20 or greater than 60 ml/min/1.73 m2. 2. Treatment with an active form of vitamin D, including Calcitriol (Rocaltrol), Paricalcitol (Zemplar) and Doxercalciferol (Hectorol) within the last 3 months. 3. Need for renal replacement therapy within the next three months. 4. History of any organ transplantation requiring immunosuppressive therapy. 5. Chronic treatment with anti-inflammatory agents including NSAIDs, steroids or cytotoxic agents. 6. Diagnoses of primary or tertiary hyperparathyroidism. 7. Serum intact parathyroid hormone (PTH) concentration greater than 250 pg/mL. 8. Serum calcium greater than 10.4 mg/dL.Serum phosphorous greater than 5 mg/dL. 9. Active malignancy. 10. History of systemic inflammatory diseases such as, systemic lupus, rheumatoid arthritis or vasculitis. 11. History of pulmonary hypertension, intracardiac shunt or unstable cardiopulmonary disease. 12. Women who are pregnant
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Bifascicular Block Syncope Evidence of Bifascicular block At least one episode of syncope during last 6 months from the enrollment Patients with Brady-tachy syndrome that needs of pacemaker to prevent the symptomatic bradycardia o symptomatic tachycardia arrhythmia Patients with vasovagal syndrome by positive TTT or carotid sinus syndrome Patients with Chronic Atrial Fibrillation Patients with Atrial Ventricular Block induces at EPS
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 50.0-85.0, Atrial Fibrillation sinus rhythm, permanent atrial fibrillation or paroxysmal atrial fibrillation selected for open heart surgery informed consent not given informed consent
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 40.0-999.0, Syncope Patients affected by severe, recurrent, certain or suspected (undetermined) reflex syncopes, aged ≥ 40 years Reflex syncopes due to reversible causes, e.g., vasoactive drugs, concomitant diseases, etc Suspected of certain cardiac syncope Syncope caused by orthostatic hypotension Non-syncopal causes of transient loss of consciousness
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Pseudoxanthoma Elasticum Male or female subject at least 18 years of age If female, the subject is not pregnant or nursing If female of child bearing potential, the subject has a negative urine pregnancy test at the first visit, and agrees to use an approved method of contraception (hormonal contraceptives [birth control pills, implants [Norplant] or injections [DepoProvera]); intrauterine device (IUD); two forms of barrier methods [condoms and diaphragm]; or abstinence (no sexual activity) throughout the entire study Biopsy confirmed diagnosis of pseudoxanthoma elasticum (documenting some calcification of elastic fibers) Subject has a clinical disease severity grade of at least "1" (Poorly defined, barely visible macules) at screening Normal kidney function tests Any subject who is pregnant or becomes pregnant during the study Subjects with a serum creatinine greater than 1.6 mg/dL Subjects with hypermagnesemia, hypokalemia, or idiopathic hypercalciuria Subjects with kidney disease or renal tubular defects (eg. Fanconi's syndrome), or on dialysis Subjects with hypothyroidism or hypoparathyroidism or primary hyperparathyroidism Subjects with acute gout Subjects with malabsorption, or osteomalacia Subjects on diuretics, magnesium containing antacids, or anabolic steroids Subjects with Cushing's syndrome Subjects receiving lithium and those with significant psychiatric disorders that would likely interfere with participation in this study
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 21.0-999.0, Chagas Disease Heart Diseases Have Chagas disease, confirmed by two serological tests Provide evidence through any of the following diagnosis methods: Rest ECG, 24 hour Holter monitoring, electrophysiological study, stress test or loop monitoring, at least one electrical disorder consistent with sinus bradycardia greater than 45 and lower than 60 bpm, sinus arrest not greater than 2.0 seconds, second degree atrial sinus block, intraventricular conduction disorders such as right branch, left branch or a bifascicular blockage type, first degree A-V blockage, or of type I second degree AV Block without associated bradycardia, atrial and/or ventricular arrhythmias that do NOT constitute an indication for pacemaker implant, ICD or mapping and radio frequency ablation Be asymptomatic or having minimal isolated unspecific symptoms not consistent with cardiac arrest, aborted sudden death, syncope, frequent and recurrent palpitations, cardiac failure, and lower extremity edema Have ejection fraction of left ventricle >35% Be able to give his/her written informed consent Subject should be > 21 years old Be able to return for follow-up visits as required Class I or II (according to AHA/HRS/ESC guidelines) indication for final implantation of pacemaker, ICD, or cardiac resynchronizer Exhibit extrinsic causes of sinus dysfunction or A-V blockage Exhibit infiltrative myocardial diseases such as tumors or associated valvular defects Suffer any concurrent disease that may limit the follow up or evaluation Suffer aftereffects of cerebral embolism Suffer ablation or isolation of pulmonary veins previous to their in the study Not being able or willing to comply with the follow-up schedule Have previous lesions of the spinal cord or aftereffects of skull trauma Have a record of epilepsy Receive pharmacological treatment for other diseases that may modify the autonomic function
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Metastatic Colorectal Cancer Patients are eligible to be included in the study if they: Are male or female; aged ≥ 18 years. Have a histologically confirmed colorectal adenocarcinoma. Have documented evidence of disease progression following at least one line of chemotherapy. Have no further standard chemotherapy options available have refused further chemotherapy. Have metastatic lesions in at least two sites in the liver (+/ other sites) suitable for bidimensional and volumetric evaluation by CT scan. Have WHO performance status of 0-2. Have a Cockcroft calculated Glomerular Filtration Rate of > 40mL/min at screening. Have a life expectancy, in the opinion of the Investigator, of > 3 months from screening. Patients are not eligible if one or more of the following statements are applicable: Patient has evidence of central nervous system metastasis. Patient has severe, active uncontrolled infection requiring systemic antibiotics, antiviral or antifungal treatments. Patient has any previous or concurrent malignancy, except adequately treated carcinoma in situ of the cervix, basal cell carcinoma of the skin and/or non-melanoma skin cancer, or if previous malignancy was more than 5 years earlier and there are no signs of recurrence. Patient has serum albumin < 30 g/L at screening. Patient has a C-reactive protein (CRP) > 70 mg/L at screening. Patient has transaminases (ALT or AST) > 5 X Upper Limit of Normal at screening. Patient has a bilirubin level > 2 X Upper Limit of Normal at screening. Patient has had radiotherapy in the 12 weeks before screening. Patient has used depot corticosteroids in the 6 weeks before screening. Patient has had chronic use of any systemic corticosteroids (> 10 mg per day of prednisolone or equivalent for a period of 2 weeks or more) and/or immunosuppressant drugs (such as azathioprine, tacrolimus, cyclosporin) within the 2-week period before the first administration of study drug. Patient of child-bearing potential who is not using an approved method of birth control (e.g., physical barrier [patient and partner], contraceptive pill or patch, spermicide and barrier, or intrauterine device [IUD]). Those patients that utilise hormonal contraceptives must have used the same method for at least three months before study dosing. Patients of non-child-bearing potential are defined as having 12 month amenorrhoea or are surgically sterile. Patient who is pregnant, breast feeding or planning a pregnancy during the course of the study. Where appropriate, a pre-treatment serum pregnancy test measuring human chorionic gonadotrophin (hCG) must be negative. Patient has been administered any investigational product in the 3 months before screening. Contraindication to CT scan, e.g., allergy to iodine based contrast medium. Patient has a surgical or medical condition which, in the judgement of the Investigator, might interfere with the activity of IMM-101, or with the performance of this study. Patient has presence of any uncontrolled concomitant disease (e.g., unstable angina pectoris, congestive heart failure, myocardial infarction, cardiac arrhythmias, uncontrolled severe hypertension) which, in the judgement of the Investigator, might interfere with the activity of IMM-101, or with the performance of this study. Patient has a history of serious adverse reaction or serious hypersensitivity to any drug that in the opinion of the Investigator may raise a safety concern. Patient has had any previous treatment with IMM-101 or related mycobacterial immunotherapy (prior BCG vaccination against TB is allowed). Patient is known to have a history of human immunodeficiency virus (HIV) or syphilis, current symptomatic Hepatitis B or C. Patient is unable or unwilling to comply with the protocol
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-90.0, Ventricular Tachycardia Catheter Ablation Tachycardia, Ventricular Age 18 to 90 years History of coronary artery disease Presence of, or planned for, an ICD prior to discharge Presentation for management of ICD shock/ATP therapy or monomorphic ventricular tachycardia Ventricular arrhythmia not thought to be due to CAD Unstable angina CVA within 30 days Protruding left ventricular thrombus or critical aortic stenosis on pre-ablation echocardiography Pregnancy Any condition resulting in an absolute contraindication to anticoagulation Inability to follow-up at ICD clinic Inability to give informed consent Non-inducible for sustained monomorphic ventricular tachycardia Prior substrate guided ablation
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Ventricular Tachycardias Patients already implanted with ICD (single-/dual -chamber, with or without cardiac resynchronization therapy) for primary or secondary prevention of sudden cardiac death Phase A General contraindication to transcatheter ablation Contraindication to antithrombotic therapy Patients chronically treated with class I and III antiarrhythmic drugs Phase B Patients developing first occurrence of incessant VTs Patients receiving a shock for first occurrence of clinically verified ventricular fibrillation Patients with aetiology differing from ischemic heart disease for coronary artery disease and from non-ischemic dilatative cardiomyopathy
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 40.0-999.0, Syncope Patients presenting to the emergency department Age > 40 years Syncope within the last 12 hours Written informed consent Age < 40 years Patients without loss of consciousness and with certain neurological causes (e.g. recurrent epilepsy, hemiplegia at presentation) No written informed consent
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Ventricular Tachycardia Ischemic Subject must be drug refractory on Class I-IV AADs (i.e., having VT episodes despite drug therapy) a. Subject must be on at least one AAD at time of enrollment 2. Qualifying episode must be sustained, monomorphic Ventricular Tachycardia post myocardial infarction 3. ICD implanted 4. 1 to 3 sustained monomorphic VT episodes requiring appropriate therapy within the previous six (6) months as determined by the investigator 5. History of myocardial infarction documented by the development of pathological Q waves with or without symptoms, imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract in the absence of a nonischemic cause, or pathological findings of a healed or healing myocardial infarction 6. 18 years or older 7. Able and willing to comply with all pre and follow-up testing and requirements 8. Signed Informed Consent Form Age < 18 years 2. Documented intra-atrial or ventricular thrombus or other abnormality on preablation echocardiogram 3. Patients with Incessant Ventricular Tachycardia (continuous sustained VTs that recur promptly despite repeated intervention for termination over several (≥ 3) hours) 4. Contraindication to anticoagulation 5. NYHA class IV 6. Left ventricular assist devices (LVADs) or other circulatory assist devices 7. Stroke as confirmed by plasma d-dimer levels or acute myocardial infarction as documented by electrocardiogram or cardiac imaging within the past three (3) months. (Note that a small cardiac enzyme release resulting from being in VT/shocks/etc. is not considered a myocardial infarction.) 8. Patients with active ischemia who are eligible for revascularization 9. Patients with idiopathic Ventricular Tachycardia or Ventricular Tachycardia of non-ischemic cause (such as nonischemic cardiomyopathy) 10. Other disease process likely to limit survival to less than 12 months 11. Serum creatinine of ≥ 2.5mg/dl 12. Thrombocytopenia or coagulopathy 13. Prior ablation for Ventricular Tachycardia 14. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal) 15. Enrollment in an study evaluating an investigational device or drug 16. Unable or unwilling to comply with protocol requirements 17. Exclusively Polymorphic Ventricular Tachycardia
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 60.0-999.0, Atrial Fibrillation Patients with recurrent paroxysmal atrial fibrillation (AF) for at least 2 years, with ≥ 2 episodes over the last 6 months; (per Amendment v3, 09APR2013, previous "6 episodes" ) 2. HATCH Score of at least ≥1 and ≤4. 3. Eligible for catheter ablation and for anti-arrhythmic or rate control medications, after having failed at least 1 but no more than 2 prescribed drugs (either anti-arrhythmic or rate control drug). 4. Age 60 years or older. 5. Left atrium (LA) diameter ≤ 55mm by TTE. 6. Left ventricle (LV) ejection fraction ≥50% when in sinus rhythm or LV ejection fraction ≥35% when in atrial fibrillation. NOTE: For patients entering the study in AF with an ejection fraction ≥35% and <50%; the ejection fraction should be re-checked when in sinus rhythm. In case the ejection fraction is >50% the subject can continue in the study. 7. Patient signed the Informed Consent Form and is able and willing to comply with protocol requirements, including all baseline and follow-up testing Patients awaiting cardiac transplantation or other cardiac surgery. 2. Acute illness (ongoing) or active systemic infection or sepsis which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant of the study. 3. Reversible causes of atrial fibrillation, e.g. but not limited to thyroid disorders, acute alcohol intoxication, recent major surgical procedures or trauma, etc. 4. Recent cardiac events including myocardial infarction (MI), percutaneous coronary intervention (PCI), or valve or bypass surgery in the preceding 3 months. 5. Heart failure decompensation. 6. Previously diagnosed with persistent/permanent atrial fibrillation/ atrial flutter. 7. Previously required cardioversion >48 hours after onset of atrial fibrillation/ atrial flutter. 8. Subject having previous transischemic attack (TIA) or stroke (cerebrovascular accident) one year prior to patient enrolment and/or no sufficient recovery. 9. Pulmonary embolism or recent atrial embolism/thrombosis. 10. Hypertrophic obstructive cardiomyopathy. 11. Class IV angina or Class IV congestive heart failure (CHF) (including past or planned heart transplantation). 12. Mandated anti-arrhythmic drug therapy for disease conditions other than atrial fibrillation. 13. Heritable arrhythmias or increased risk for torsade de pointes with class I or III Drugs. 14. Prior left atrial catheter ablation with the intention of treating atrial fibrillation; prior surgical interventions for AF such as the MAZE procedure. 15. Prior AV nodal ablation. 16. Patients presenting contra-indications for the study catheter(s), as indicated in the respective Instructions For Use. 17. Contraindication to warfarin, other anticoagulation therapy, or all anti-platelet medications. 18. Medical conditions limiting expected survival to <3 years. 19. Concurrent participation in any other clinical study. 20. Prior history of non-adherence to prescribed drug regimens. 21. Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the trial NOTE: Prior ablation of the cavo-tricuspid isthmus is not a reason to if the patient develops subsequent recurrent atrial fibrillation. NOTE: For patients randomized to the PVI group (Test Group), a Transesophageal Echocardiography (TEE) should be performed (as per standard of care), within 48 hours pre-procedure, to atrial thrombus or other structural contraindications for an ablation procedure
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 0.0-999.0, Coronary Artery Disease Male patient with coronary artery disease Stable medication Physically stable Psychologically stable Written informed consent Willing and able to comply with all trial requirements Must have completed rehabilitation program since at least 6 months and no longer than 5 years prior to study begin Acute coronary syndrome within the last three months Abnormal high hepatic enzymes Renal insufficiency with compensated retention Intake of medication which may affect endothelial function Currently smoking Current malignant diseases, which may reduce the expectancy of life Chronic heart failure Insulin-dependent diabetes Known hypersensitivity against any ingredient of PADMA 28 Longterm intake of supplements
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Ischemic Heart Disease Man or post-menopausal woman or with an oral contraceptive treatment , > 18 years Provided written consent by patient with good understanding of the study objectives as explained by the investigator during the initial visit Patient with a potential or known Coronary Artery Disease Patient for whom transthoracic ultrasonography for coronary reserve assessment is deemed useful Subjects under 18, pregnant or breast-feeding woman, psychotic patients or subjects placed under administrative and legal authority Patients judged by investigator as not able to understand the study objectives Patients with a medical history, in particular a heart disease history (eg AV block) judged as non eligible by investigator Patients whose medical treatment contra indicates their in the study (eg chronic use of oral dipyridamole, pentoxifylline), if not stopped at least 72 hours before the study test Patients with symptomatic bradycardia (<40 beat/min) or with systemic hypotension (SBP > 90 mmHg Patients with a 2nd and 3rd degree AV block, a sick sinus syndrome, but not those with artificial pacemaker Patients with prolonged QT (QTc>480 ms) Patients with oral dipyridamole who did not stopped their medication 48hrs before the study test Patients who received theophylline within 5 days before study test
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1
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, ICD Sudden Cardiac Death Ventricular Fibrillation Atrial Fibrillation Ventricular Tachycardia Subject implanted with a single, dual, or triple chambers ICD within the last 3 months Home Monitoring® activated and functional since hospital discharge Patient willing and able to comply with the protocol and who has provided written informed consent about Home Monitoring® Patient whose medical situation is stable ICD replacements New York Heart Association Function Class IV patients Pregnant women or women who plan to become pregnant during the trial Presence of any disease, other than patient's cardiac disease, associated with reduced likelihood of survival for the duration of the trial, e.g. cancer, uraemia (urea > 70mg/dl or creatinine >3mg/dl), liver failure, etc Age < 18 years Patient unable to handle the Biotronik's transmitter correctly Change of residence expected during the study Insufficient global system for mobile communication (GSM) coverage at patient's home Participation in another clinical study
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-79.0, Congestive Heart Failure Left Ventricular (LV) Systolic Dysfunction Candidates for this study must meet ALL of the following Clinical Age ≥ 18 and ≤ 79 years Body Mass Index (BMI) ≤ 40 Symptomatic ischemic heart failure (New York Heart Association (NYHA) Class III or "ambulatory" Class IV as determined through the use of the SAS) post Myocardial Infarction (MI) in the Left Anterior Descending (LAD) territory at least 60 days prior to enrollment Patient is not hospitalized at the time of enrollment Receiving appropriate medical treatment for heart failure according to the current American College of Cardiology (ACC)/American Heart Association (AHA) Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult during the three months prior to enrollment The patient or the patient's legal representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site The patient and the treating physician agree that the patient will return for all required post-procedure follow-up visits. based on Imaging ≤ Left Ventricular Ejection Fraction (LVEF) ≤ 35% by Transthoracic Echocardiogram (TTE) Post LV MI structural heart dysfunction represented by LV wall motion abnormality (WMA) by TTE Untreated clinically significant coronary artery disease requiring revascularization Cardiogenic shock within 72 hours of enrollment Patient has received a pacemaker, Implantable Cardioverter Defibrillator (ICD), or Cardiac Resynchronization Therapy (CRT) within 60 days of enrollment Excessive wall motion abnormalities outside the anteroapical region Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA) End stage renal disease requiring chronic dialysis Obstructive Sleep Apnea (OSA): unless compliant on CPAP therapy or successful surgery Hemoglobin < 10 g/dl (female), < 12 g/dl (male) or Creatinine > 2.5mg/dl Blood dyscrasia, history of bleeding diathesis or coagulopathy, or hypercoagulable states Active peptic ulcer or GI bleeding within the past 3 months
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Atrial Fibrillation Tachycardia, Ventricular Be in sinus rhythm Have the ability to provide informed consent for study participation and be willing and able to comply with the Clinical Investigational Plan described evaluations Be undergoing mapping and ablation that requires left heart access for either ventricular tachycardia (VT) or atrial fibrillation (AF) according to HRS (Heart Rhythm Society)/ESC (European Society of Cardiology)/German National guidelines. The patient needs to have at least one of the following indications for left heart mapping and ablation to be included in the study: a) Symptomatic sustained monomorphic VT (SMVT), or b) Frequent PVCs, non-sustained VT, or VT that is presumed to cause ventricular dysfunction, or c) Bundle branch reentrant or interfascicular VTs, or d) Symptomatic AF with indication for ablation per current HRS/ESC/German National guidelines in a patient who is either 1) refractory or intolerant to at least one Class 1 or Class 3 antiarrhythmic medication, or 2) unable/unwilling to take antiarrhythmic drug therapy and chooses ablation as the first line of therapy Have permanent AF Exhibit Cheyne-Stokes respiration Have a recent myocardial infarction within 40 days prior to enrollment Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures Have had a recent CVA or TIA within 3 months prior to enrollment Be less than 18 years of age Be pregnant Be currently participating in any other clinical investigation
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Arrhythmias, Cardiac Tachycardia, Ventricular Myocardial Infarction Cardiomyopathies Consecutive patients with ventricular arrhythmias due to ischemic heart disease or dilated cardiomyopathy undergoing VT ablation Age <18 years, absence of signed informed consent or critical clinical status that precludes a detailed mapping procedure
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 21.0-999.0, Acute Coronary Syndrome Chest Pain Age greater than or equal to 21 years Chest discomfort or other symptoms consistent with possible ACS The treating physician feels the patient could be discharged home if cardiac disease was excluded New ST-segment elevation in contiguous leads on any electrocardiogram (>/= 1 mV) Unstable vitals signs: symptomatic hypotension at the time of enrollment (systolic < 90 mm Hg), tachycardia (HR>120), bradycardia (HR<40), and hypoxemia (<90% pulse-oximetry on room air or normal home oxygen flow rate) Terminal diagnosis with life expectancy less than 1 year A non-cardiac medical, surgical, or psychiatric illness determined by the provider to require admission, increase risk of objective cardiac testing, or prevent immediate discharge following negative testing Prior enrollment Incapacity or unwillingness to provide consent and comply with study procedures Non-English speaking Sub-study I & II ED attending physicians ED attending physicians who decline to participate
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Coronary Artery Disease Adult Age ≥ 18 years Presenting with symptoms suggestive of CAD requiring diagnostic/prognostic workup Suitable for Contrast Stress Echocardiography, SPECT and CCTA Able and willing to provide consent Patients with documented CAD (previous invasive angiography, previous STEMI, previous PCI or CABG) ACS within 3 months Previous diagnostic imaging tests in the past 6 months Women who are pregnant as evidenced by positive pregnancy test Breast feeding females Significant valvular heart disease (i.e. severe aortic stenosis or regurgitation or severe mitral regurgitation) Hemodynamic instability (blood pressure >210/110 ml/Hg or <90/60 mm/Hg) Unavailability for follow-up Renal insufficiency, eGFR < 30 ml/minute unless on dialysis Known allergy to x-ray or echo contrast agents
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1
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Coronary Artery Disease The patient is implanted with an St Jude Medical (SJM) ICD with ST Monitoring and ShockGuard™ features (and remote care feature in case Merlin.net will be used) The patient, in the opinion of the investigator, will not require ventricular pacing for more than 20% of the time The patient, in the opinion of the investigator, has or is at high risk of Coronary Artery Disease (CAD) The patient is ≥ 18 years of age The patient is able to provide written Informed Consent prior to any investigational related procedure The patient has longstanding persistent Atrial Fibrillation (AF) /Atrial Flutter (AFl) or permanent AF/AFl The patient has documented complete heart block The patient is known to have uncontrolled ventricular bigeminy or trigeminy (PVCs on regular basis) The patient has severe Left Ventricular Hypertrophy resulting in interventricular conduction defect (IVCD) The patient has intermittent bundle branch blocks (BBB) The patient is unable to comply with the follow up schedule The patient is participating in another investigational device or drug investigation The patient is pregnant or is planning to become pregnant during the duration of the investigation
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Atrial Fibrillation With 2 or 3° AV or Bifascicular Bundle Branch (BBB) Block Normal Sinus Rhythm With 2 or 3° AV or BBB Block Sinus Bradycardia With Infrequent Pauses or Unexplained Syncope With EP Findings Subject must have one of the following clinical indications: 1. Chronic atrial fibrillation with 2 or 3° AV or bifascicular bundle branch block (BBB block) ; or 2. Normal sinus rhythm with 2 or 3° AV or BBB block and a low level of physical activity or short expected lifespan (but at least one year); or 3. Sinus bradycardia with infrequent pauses or unexplained syncope with EP findings; and Subject ≥18 years of age Subject has life expectancy of at least one year Subject is not enrolled in another clinical investigation Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the EC If female, for 3 months post-operative, subject will actively practice a contraception method, or will practice abstinence, or is surgically sterilized, or is postmenopausal Pacemaker dependent Known pacemaker syndrome, have retrograde VA conduction or suffer a drop in arterial blood pressure with the onset of ventricular pacing Hypersensitivity to < 1 mg of dexamethasone sodium phosphate Mechanical tricuspid valve prosthesis Pre-existing pulmonary arterial (PA) hypertension or significant physiologically-impairing lung disease Pre-existing pacing or defibrillation leads Current implantation of an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) Presence of implanted vena cava filter Presence of implanted leadless cardiac pacemaker Pregnant or breastfeeding
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, ATRIAL FIBRILLATION, Syncope Suspected cardiac arrhythmia OR Previous AF diagnosis OR AF diagnosis before or after ablation procedure OR Stroke of unknown origin Implanted ICD or cardiac pacemaker Allergy to patch electrodes
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Septic Shock Left Ventricular Systolic Dysfunction Left Ventricular Diastolic Dysfunction Adult patients admitted to ICU for severe sepsis or septic shock Expected ICU stay <24hrs Patients in which mental inabilities or language barriers impair the possibility of informed consent
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-75.0, Pain Disorder Sensory Deficit Adults ASA physical status I-III BMI<30 No contraindications to study procedures Pediatric patients ASA physical status IV BMI>30 Contraindications to study procedures Hypersensitivity to local anesthetics
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 0.0-999.0, Critical Limb Ischemia Subjects should have diagnosed Rutherford classification Grade 3, Category 5 or 6 (Fontaine stage IV) treatment-resistant chronic critical limb ischemia having tissue loss, not relieved by maximal medical therapy and they should have exhausted or not be candidates for surgical (other than heart transplant) or percutaneous intervention Male Age: 18 to 80 years Current non-smokers BMI >19 Estimated 6 month survival rate >90% Concomitant stable medications will be allowed If the subjects have coronary artery disease established by history, angina pain, EKG, Lab including Troponin I, creatine kinase, lactate dehydrogenase, Echocardiography, Thallium scan or coronary angiography, the subjects should have established a classification of coronary artery involvement by coronary angiography or other procedure with similar precision Anemia Low blood pressure (systolic < 120 mmHg) Baseline hematocrit < 30 Initial whole blood viscosity measurements below 15 miliPoiseille
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-80.0, Ventricular Tachycardia structural heart disease (CAD, DCM, ARVC) ICD already implanted documented ventricular tachycardia patient is able to give informed consent VT ablation because of vital indication VT without structural cardiac disease VT not documented patient is not able to give informed consent contraindication for pericardial puncture mechanical aortic valve pacemaker or ICD with an epicardial lead
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0
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