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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 Subject must be undergoing implant of a commercially approved ICD system Subject must be willing to provide Informed Consent Subject must be > 18 years old Subject with impaired kidney function as measured by a glomerular filtration rate (eGFR) estimate < 29 mls/min/1.73m2 (recorded in the last six months) Subject has high risk of infection Subject has EF < 15% Subject at high risk of stroke having a device replacement Subject with an implanted active non-ICD device, cardiac or non-cardiac (e.g., Neuro stimulator, Pacemaker) Subject is indicated for CRT Subject is pacemaker dependent Subject enrolled in a concurrent study that may confound the results of this study Subject has medical conditions that would limit study participation
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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, Transcatheter Aortic Valve Implantation Existence of senile degenerative aortic stenosis with a transvalvular gradient by> 40 mmHg and / or maximum velocity> 4 m / sec and / or initial valve area <1 cm ² (indexed <0.6 cm ² / m²). The initial measurement of valve area must be obtained within 30 days prior to valve implantation 2 Presence of symptoms related to aortic stenosis (dyspnea, angina, syncope effort ...) demonstrated by Functional Classification for Congestive Heart Failure functional class> 2 or Class I, but with left ventricular dysfunction (ejection fraction <40% ) 3 A Score to "EuroSCORE" (Logistic European system for cardiac operative risk evaluation) > 20% and / or Society of Thoracic Surgeons' risk Calculator> 10. In case the "EuroSCORE" <20% or STS <10, confirmed that some comorbidities were not captured by these indices will be produced by the surgeon and cardiologist Some patients are in a situation against medical-cardiac surgery indicates heavy although this does not appear in the predictive risk assessment through the scores. In this regard, patients may be included in the following conditions: 3-1 ascending aorta very calcified ("porcelain") 3-2 Any other condition preventing cannulation for cardiopulmonary bypass, aortic clamping, or access mediastinal surgery: History of 3-2-1 against mediastinal irradiation indicating open-chest 3-2-2 thoracic deformity or history of mediastinitis-cons indicating the opening of the thorax 3-2-3 Other (eg, history of coronary bypass surgery may indicate against the opening of the thorax) 4 The patient accepts the scheduled evaluations at follow-up clinic 5 The patient or his legal representatives were informed of the nature of valve implantation and associated register and accept the conditions none
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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, Pain, Shoulder Male and females of 18-80 years of age, scheduled to undergo elective shoulder arthroplasty. 2. ASA Class I, II, III Patients with associated significant cardiac and respiratory disease. 2. Patients who will need hospitalization due to reason other than the planned surgery. 3. Patients with coexisting sleep apnea or morbid obesity (BMI> 35). 4. Patients with pre-existing major organ dysfunction such as hepatic and renal failure. 5. Psychiatric illnesses. 6. Lack of informed consent. 7. Allergy to any of the drugs used in the study. 8. Contraindications to interscalene block
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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, Ventricular Tachycardia Coronary Artery Disease Sustained monomorphic VT (>30 seconds, or requiring appropriate ICD therapy in patients with ICDs) Documented ischemic heart disease with no further options for revascularization Ability and willingness to give written informed consent to participate in the trial VT in the setting of metabolic abnormalities or acute ischemia if coronary lesions suitable for revascularization are identified Acute ischemia with for revascularization Significant peripheral arterial disease preventing transvascular access to the left ventricle Patients with arrhythmogenic right ventricular cardiomyopathy (ARVC), hypertrophic cardiomyopathy, Brugada syndrome, Long QT syndromes, dilated cardiomyopathy Prior long term therapy with a Class III or Class IC antiarrhythmic agent (longer than 2 weeks) Patient is or may be potentially pregnant Patient has a mechanical heart valve Myocardial infarction within the past 90 days Stroke within the past 90 days New York Heart Association (NYHA) functional class IV
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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, Syncope age≥60 years; AND 2. a complaint of syncope or near-syncope. Syncope is defined as a transient loss of consciousness (LOC), associated with loss of postural tone, with immediate, spontaneous, and complete recovery. Near-syncope is the sensation of imminent syncope without loss of consciousness Seizure as presumptive cause of LOC Stroke or transient ischemic attack as presumptive cause of LOC LOC AFTER head trauma Confusion from baseline mental status Intoxicated (alcohol or other drugs) Medical or electrical intervention to restore consciousness Hypoglycemia as presumptive cause of LOC inability to provide follow-up information, including patients who do not speak English (or Spanish, if applicable for study site), lack phone access, or lack a permanent address Inability or unwillingness of individual or legal guardian/representative to give 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): 18.0-60.0, Neuromediated Cardioinhibitory Syncope Twenty consecutive patients affected by cardioinhibitory neurocardiogenic syncope will be enrolled in the study age between 18 and 60 years syncopal episodes at least of likely CNS in the previous 2 years marked cardioinhibitory response to HUT or documented asystolic pauses at internal loop recorder registration [7]. Cardioinhibition will be considered as elicitation of asystolic pause (sinus arrest or AV block) ≥ 3 seconds associated to syncope or ≥ 6 seconds and related presyncope documented myocardial and/or valvular abnormalities on 2D echocardiogram (ejection fraction lower than 50%) documented tachyarrhythmias as possible causes of symptoms channelopathies (Brugada syndrome, LQT or SQT syndrome) ventricular preexcitation symptomatic orthostatic hypotension diagnosed by standing blood pressure measurement pregnancy in women previous cardiac pacemaker implantation
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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, Cardiomyopathy Ischemic Cardiomyopathy Ischemic cardiomyopathy Intrinsic QRS duration >120 milliseconds LV ejection fraction <40% Persistent atrial tachyarrhythmia Active cardiac ischemia Cerebrovascular accident within 6 months Surgical or percutaneous cardiac revascularization procedure within 3 months Under 18 years of age Pregnant Participating in a clinical study that would preclude enrollment Unable to provide 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, Primary Care Phase I VA patients who have had some experience with care receipt through technology (e.g., home telehealth, CVT, secure messaging with providers) A second group will be conducted with patients who have not had experience receiving care through technology There are no other specific and the investigators plan to recruit both male and female Veterans, as well as minorities. Phase II Veterans who receive care from VA and are comfortable using the Internet There are no other specific and the investigators plan to recruit both male and female Veterans, as well as minorities. Phase III Veterans who receive care from Hines VA or Jesse Brown VA in a primary care/PACT clinic No subjects will be excluded based on gender, race, or ethnicity (1) adult, age 18 or over (2) assigned primary care provider in PACT clinic A history of dementia Blindness
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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 Sudden Death Syncope Chest Pain individuals aged between 18 and 80 years old life expectancy greater than 1 year positive reaction in at least two different serologic techniques for Chagas disease (ELISA, indirect hemagglutination or indirect immunofluorescence) symptomatic recurrent monomorphic ventricular tachycardia (recorded by holter, electrocardiogram or looper) prior to implantable cardioverter defibrillator implantation in patients with ventricular tachycardia as an attempt to prevent shoks patients in "electrical storm", defined as three or more episodes of ventricular tachycardia in 24h. Each episode must demand a medical intervention monomorphic ventricular tachycardia induced during electrical physiological study in patients with syncope of unexplained cause claustrophobia creatinine clearance inferior to 30ml/min/m2 (clearance between 30ml/min/m2 and 60ml/min/m2 will be analyzed individually) thrombus in the left ventricle pregnancy heart failure NYHA IV allergy to iodinated contrast or gadolinium patients with implantable devices (pacemakers, implantable defibrillators and similar) coagulopathy (INR > 1,5 or aPTT 2x normal values) platelet count inferior to 100.000
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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): 18.0-60.0, Fetal Arrhythmia Abnormality in Fetal Heart Rate or Rhythm Long QT Syndrome Normal subjects: normal, healthy adult women with uncomplicated pregnancies High-risk cohort: The primary criterion is diagnosis of serious fetal arrhythmia, which is defined as sustained low or high heart rate. Low heart rate, or bradycardia, and high heart rate, or tachycardia, are based on normative values for gestation (usually below 110 -120 beats/min, or above 160-180 beats/min). Intermittent bradycardia and tachycardia are also important to detect because these arrhythmias may become incessant over the course of pregnancy and have implications for patient management. Abnormal repolarization, such as long QT syndrome (LQTS), is another important class of arrhythmia. Fetuses with a family history of LQTS or a suspicious rhythm (low heart rate, intermittent AV block, or ventricular tachycardia) will also be studied The pregnant women subjects must by aged 18 or older. High-risk subjects cannot participate if their physician in consultation with the lead physician of the study does not grant permission for them to participate in the study due to risk of travel or other reason
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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 Age ≥ 18 years Initial ICD implantation (single, dual, or CRT) for a standard Class I or Class II indication according to the ACC/AHA/HRS practice guidelines Anticipated life expectancy >6 months Contraindications to defibrillation testing as determined by the managing physician* ICD replacement implants Right-sided pectoral implants Abdominal implants Chronic oral amiodarone therapy (for >6 weeks and continued need for amiodarone) Inability to give informed consent Contraindications to defibrillation testing the following: hemodynamic instability, LA thrombus, atrial fibrillation without adequate anticoagulation, LV thrombus, recent CVA or TIA, severe unrevascularized coronary artery disease or unstable angina, severe aortic stenosis, inotropic dependence, patient refusal, other patient-specific medical conditions that are deemed as contraindications, as determined by the implanting physician
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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 Tachyarrhythmias ICD Shock Therapy ICD Shock Burden age > 18 years implanted ICD occurrence of pacemaker-induced VT documentation of pause-related syncope AV block sick-sinus syndrome younger than 18 years
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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, (Near) Syncope (near) syncope age < 18 years progressive impairment of consciousness use of mind-altering drugs non syncopal loss of consciousness: hyperventilation, hypoglycaemia, metabolic disorders, psychogenic pseudosyncope, TIA or stroke, seizure, transient loss of consciousness caused by craniocerebral injury
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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 Physicians are participants in the Electronic Medical Record Administrative-data Linked Database (EMRALD) Patients are rostered to participating physicians, with a diagnosis in the chart of atrial fibrillation Physicians who do not consent to data sharing Patients who change physicians during the course of 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): 18.0-80.0, Monitor Adverse Events 2.1 Patient with histologically confirmed diagnosis of prostate cancer. 5.2.2 Patient with rising serum PSA,(prostate specific antigen). 5.2.3 Tumor is hormone refractory, as documented by rising PSA with two values separated in time. Patients may enroll if they have a rising PSA after withdrawal of androgen therapy but if enrolled onto this protocol on androgen ablation therapy, they must remain on the androgen therapy for the duration of this protocol. Patients may enroll if tumor is not hormone refractory only if they refuse hormone therapy at this time, and that they understand that hormone therapy is standard treatment for their disease at this stage. 5.2.4 Patient must be at least 18 years of age. 5.2.5 Patient able to understand and sign informed consent. 5.2.6 Patient with a life expectancy of greater than four months. 5.2.7 Patient with performance status of 0 to 1. (http://www.ecog.org/general/perf_stat.html). 5.2.8 Patient with adequate organ function as defined by: 5.2.8.1 ANC 1.0, platelets 50,000, Hgb 8.0; patient may be transfused to achieve Hgb 8.0 to satisfy enrollment or as otherwise indicated by symptoms for Hgb >8.0. 5.2.8.2 Creatinine 1.5mg/dl or creatinine clearance 60cc/min. 5.2.8.3 Direct bilirubin 1.5 mg/dl. 5.2.8.4 No evidence of congestive heart failure, symptoms of coronary artery disease, serious cardiac arrhythmias, including atrial fibrillation/atrial flutter, evidence of prior myocardial infarction by history or EKG. A normal cardiac stress test for inducible ischemia or arrhythmia within 12 weeks prior to enrollment for all patients over 50 years old or those with abnormal EKG or any history or symptoms suggestive of cardiac disease. 5.2.8.5 No serious, symptomatic obstructive or emphysema¬tous lung disease, or asthma requiring intravenous medications within the past 12 months; no serious lung disease associated with dyspnea at normal activity levels (grade III) or at rest (grade IV), due to any cause (including cancer metastases and pleural effusions). The patient will be ineligible if PFTs show an FEV1 <1.3 liters or a DLCO <50% within 12 weeks of study entry. For patients enrolling in cohorts IIA, IIB, and III: 5.2.9 Patients with disease in the bone or other site(s) have biopsy-able tumor (at radiologically or externally-accessible site), and willing to undergo biopsy as specified in 6.3.6. For these groups, patients with >5 lesions bone scan positive lesions will be preferred to increase the yield of blind bone marrow biopsies. Alternatively, patients with bone or extra-skeletal lesions may be biopsied by CT guided or open procedure 3.1 Patients with serious or unstable renal, hepatic, pulmonary, cardiovascular, endocrine, rheumatologic, or allergic disease based on history, physical exam and laboratory tests will be excluded, as outlined in section 5.2.9. 5.3.2 Patients with active clinical disease caused by CMV, hepatitis B or C, HIV or tuberculosis will be excluded from the study. 5.3.3 Patients who have had cytotoxic and/or radiation therapy in the four weeks prior to entry or who have initiated anti-androgen therapy less than six weeks prior to entry will be excluded. 5.3.4 Patients with other concurrent malignancies will be excluded. 5.3.5 Patients requiring systemic steroids will be excluded. 5.3.6 Patients with prior investigational therapies within the 4 weeks prior to entry will be excluded. 5.3.7 Patients previously exposed to mouse antibody will be excluded, unless proven by ELISA to have a negative baseline human anti-mouse antibody (HAMA) titer. 5.3.8 Patients who have had irradiation to whole pelvis or to more than 25% of total marrow will be excluded
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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): 18.0-100.0, Diabetes Mellitus Cardiovascular Disease Healthy Volunteer Inflammation Cardiovascular Disease Females and males 18 years of age or older Diagnosis of clinical CAD (including abnormal EKG with a prior infarction pattern, abnormal echo consistent with a wall motion abnormality or a referral note from cardiologist with diagnosis of CAD) CAD that is currently stable (defined by no change in medications for blood pressure, angina or diuretic therapy or in no new CV symptoms over the past month in a patient who has had a primary cardiac event or an abnormal EKG with confirmed wall motion abnormality) CAD which may be associated with chronic stable angina (defined by a clinical syndrome characterized by discomfort in the chest, jaw, shoulder, back, or arm by a physician) CAD that is found on CCTA which may be subclinical Pregnant women or lactating women For optional adipose biopsy, any subject with known bleeding disorder, current fever or on anti-coagulation For optional MRI, inability to participate due to metal within body, claustrophobia, or anything else that prohibits undergoing a MRI scan Any solid organ or liquid tumor within the past five years, with the exception of nonmelanomatous skin cancer Active infectious diseases within 3 months requiring antibiotics, collagen vascular diseases such as RA, psoriasis and mixed connective tissue diseases and immune-mediated lung diseases (e.g. IPF, BOOP) A BMI >40 kg/m(2) due to PET MRI restrictions Subjects with severe renal excretory dysfunction, estimated glomerular filtration rate < 30 mL/min/1.73m(2) body surface area according to the Modification of Diet in Renal Disease will not receive the cardiac CT angiography, or gadolinium contrast agent during the PET/MRI Subjects with second -or third-degree AV block or sinus node dysfunction will not receive the 13N-ammonia PET/CT imaging unless these patients have a functioning artificial pacemaker Subjects with any signs or symptoms of acute coronary syndrome, including vasoreactive hypertension with blood pressure exceeding 180/100, any concerning ST segment changes on ECG, or acute chest pain, will not receive the 13N-ammonia PET/CT imaging. Diabetes Mellitus Females and males 18 years of age or older
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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, Cardiomyopathy, Dilated Tachycardia, Ventricular Ventricular Fibrillation group A Nonischemic cardiomyopathy Documented ventricular arrhythmia, suspected ventricular arrhythmia (e.g. because of out-of-hospital cardiac arrest, palpitations or syncope) or high risk for ventricular arrhythmias (LVEF ≤ 35%) or intermediate risk for ventricular arrhythmias (LVEF ≤ 50% and late enhancement on contrast-enhanced MRI) Admission not for cardiac surgery group B Nonischemic cardiomyopathy Documented ventricular arrhythmia or suspected ventricular arrhythmia (e.g. because of out-of-hospital cardiac arrest, palpitations or syncope) or high risk for ventricular arrhythmia (LVEF ≤ 35%) Admission for cardiac surgery (e.g., mitral valve annuloplasty or CorCap) group C Patients undergoing aortic valve replacement or coronary artery bypass graft surgery all groups Age < 18 years or > 80 years Inadequate patient competence Pregnancy Inability to comply with the protocol due to haemodynamic instability groups A and B Other cardiomyopathy (e.g., prior myocardial infarction, infiltrative cardiac disease such as sarcoidosis, amyloidosis or Chagas cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy/dysplasia, hypertrophic cardiomyopathy, non-compaction cardiomyopathy and congenital heart disease) group C Nonischemic cardiomyopathy Prior myocardial infarction
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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, Ischemic Heart Disease The subject is > 18 years of age at the time of consent 2. Subjects experiencing clinical symptoms considered suggestive of ischemic heart disease (eg, chest pain or discomfort or symptoms considered by the investigator to represent anginal equivalents) or having evidence of myocardial ischemia (eg, abnormal functional study) attributed to the CTO target vessel and scheduled for clinically indicated percutaneous CTO revascularization or are subjects with multi-vessel disease and/or Acute Coronary Syndrome (ACS) that are undergoing a staged CTO PCI procedure with the intent to achieve complete revascularization. 3. Subject must have at least 1 target segment meeting non-acute total coronary occlusion as defined below. A CTO is any non-acute total coronary occlusion fulfilling the following angiographic characteristics and: 1. High-grade native coronary stenosis 2. Thrombolysis in Myocardial Infarction (TIMI) 0 or 1 antegrade flow 3. Estimated in duration at least 3 months by clinical history and/or comparison with antecedent angiogram, functional study or electrocardiogram 4. CTO segment may be de novo or previously treated via PCI 4. Subject is eligible and consents to undergo or has undergone a PCI procedure 5. Subject is an acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA) and stenting. 6. Subject is willing and able to provide informed consent as approved by local Institutional Review Board/Ethics Committee and to complete the protocol requirements for the study. 7. Female subjects of child-bearing potential with a negative qualitative or quantitative pregnancy test in accordance to the Piedmont Hospital Policy Any known allergy, hypersensitivity or contraindication to iodinated contrast that cannot be effectively managed medically 2. Any known allergy, hypersensitivity or contraindication to clopidogrel bisulfate (Plavix®), prasugrel (Effient®) or ticagrelor (Brilinta®)- for which alternative agents cannot be used- or aspirin, heparin, nickel, stainless steel, zotarolimus, or everolimus 3. Any contraindication to cardiac catheterization or to any of the standard concomitant therapies used during routine cardiac catheterization and PCI 4. Subjects with any other pathology or indication which in the opinion of the investigator, might put the subject at risk, preclude follow-up, or in any way confound the results of the study 5. Known previous medical condition yielding expected survival less than one year 6. Subjects who are unable or unwilling to comply with the protocol or not expected to complete the study period, including its follow-up requirements 7. Subjects with evidence of ongoing or active clinical instability including any of the following: 1. Sustained systolic blood pressure < 100 mmHg (if different from baseline) or cardiogenic shock 2. Acute pulmonary edema that has not been medically stabilized 3. Suspected acute myocarditis, pericarditis, endocarditis, or cardiac tamponade 4. Suspected dissecting aortic aneurysm 8. Subjects with known clinically significant abnormal laboratory findings including: 1. White Blood Cells (<1,000 WBC/mm3) 2. Thrombocytopenia (<100,000 platelets/mm3) 9. Subjects with history of bleeding diathesis or coagulapathy or refusal of blood transfusions 10. Female subjects of child-bearing potential with a positive qualitative or quantitative pregnancy test or with a negative qualitative or quantitative pregnancy test who plan to become pregnant within 12 months of enrolling in 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): 18.0-60.0, Epilepsy Asystole Cardiac Arrhythmias Drug-resistant focal epilepsy: failure of adequate trials of two tolerated and appropriately chosen and used antiepileptic drug (AED) schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom [16] ≥ 1 complex partial and/or generalized tonic clonic seizure/month as indicated by history taking If female, not pregnant Aged 18 to 60 years Able to undergo the study procedure as judged by the treating physician Clinical suspicion of seizure-induced asystole (e.g. seizures with sudden flaccid falls) Reveal implantation (either present or in the past) Known clinical relevant structural cardiac disease Hereditary syndromes that increase the risk of cardiomyopathy (e.g. Marfan's disease) ECG findings suggestive of arrhythmias without proper cardiac evaluation to in or this possibility. According to European Society of Cardiology (ESC) guidelines on syncope the following ECG findings will be used: bifascicular block and other intraventricular conduction abnormalities, asymptomatic inappropriate sinus bradycardia (<50 bpm), sinoatrial block or sinus pause ≥3s in the absence of negative chronotropic medications, non-sustained VT, pre-exited QRS complexes, prolonged or short QT interval, Brugada pattern, pattern suggestive of arrhythmogenic right ventricular cardiomyopathy Pacemaker Use of beta blockers or other anti-arrhythmic/anti-arrhythmogenic medication Previous diagnosis of psychogenic non-epileptic seizures Patients who live alone and are not able to recall their seizures
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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, Patients With Symptoms of Cardiac Arrhythmia at Risk for Atrial Fibrillation Symptoms of high clinical suspicion for atrial fibrillation prompting referral for ambulatory cardiac rhythm monitoring for potential atrial fibrillation. AND At high risk for atrial fibrillation, defined as any one of the following: ischemic stroke with no defined etiology (In prior 6 months) [3, 4, 6, 7], hypertension [33], increased body mass index (BMI >30kg/m2) [33], heart failure [33], clinically significant murmur [33], prolonged PR interval on resting ECG [33], chronic kidney disease [34], hypertrophic cardiomyopathy [35], congenital heart disease [36], chronic obstructive pulmonary disease [37, 38], sleep apnea [39-41], thyroid disease [42, 43], family history of atrial fibrillation [44], diabetes [45] or excess alcohol consumption (Male > 14 drinks/week, Female >7 drinks/week)[46] Age 40 years or older Capable of providing informed consent Capable of wearing a Zio Patch for up to 14 days Capable of providing a blood sample Previously documented atrial fibrillation or atrial flutter Prior cardiac surgery (coronary artery bypass grafting, valve replacement or repair, pericardial stripping, etc) within the past 30 days Hyperthyroidism Have known skin allergies, conditions, or sensitivities (e.g. allergy to adhesives, psoriasis) as the Zio Patch should not be used on patients with known skin allergies, conditions, or sensitivities Are receiving pacing therapy Are anticipated to receive or require external cardiac defibrillation during the monitoring period Are anticipated to have exposure to high frequency surgical equipment during the monitoring period
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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 Age 18 or above, and capable of giving informed consent Scheduled for a clinically indicated cardiac ablation for the treatment of ventricular tachycardia Moderate or severe aortic stenosis or mitral stenosis Active infection Presence of thrombus, cardiac tumour, interatrial Baffle patch (a specific form of congenital cardiac surgery) or prior septal occluder device Subjects who cannot be anticoagulated of infused with heparinized saline A history of heparin induced thrombocytopenia Pregnant or actively breast feeding
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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): 18.0-65.0, Healthy The subject signs an IRB/IEC-approved informed consent prior to any study-related procedures. 2. Subject is male or female with no less than 6 subjects per sex in the study. 3. Subject is 18 to 65 years of age. 4. Subject's BMI is ≤32 kg/m2. 5. Female subjects of childbearing potential must not be pregnant or lactating with a negative serum HCG pregnancy test result at Screening and a negative urine HCG pregnancy test result on Days -1 and 14 prior to receiving study medication. 6. Female subjects of childbearing potential and male subjects must use an adequate method of contraception from Screening until completion of the study. Acceptable methods of contraception are barrier methods (male condom, female condom, diaphragm, cervical cap, spermicide or IUD), surgical sterility (documented doctor's report of vasectomy, hysterectomy and/or bilateral oophorectomy) and/or postmenopausal status (defined as at least 1 year without menses as demonstrated by medical history or subject report). 7. Subject is in good health as determined by vital signs, medical history, physical exam, and safety laboratory analyses at Screening and during the study Subject has used an investigational product within 30 days prior to screening or during the study. 2. Subject has used prescription or non-prescription drugs (including vitamins, minerals, and herbal/plant-derived preparations) within 2 weeks of Screening (excluding oral contraceptives, hormonal IUD, hormone replacement therapy and acetaminophen) unless deemed acceptable by the Investigator in consultation with the Sponsor. 3. Subject has a positive drug and/or alcohol test at Screening, Day -1 or Day 14. 4. The subject has a history of drug or alcohol abuse within 2 years before Screening. 5. The subject is unable to abstain from ingesting alcohol, caffeine, grapefruit or Grapefruit juice for 72 hour prior to dosing. 6. The subject has a clinically significant history of cardiovascular, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major diseases or malignancy. 7. Subject has a history of cardiac disease or any risk factors for TdP including (but not limited to) unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia, structural heart disease and family history of Long QT syndrome. 8. Subject has evidence of any of the following cardiac conduction abnormalities at Screening, Day -1 or Day 1 prior to receiving any study medication: 1. QTcF interval >430 msec for males and >450 msec for females 2. PR interval >240 msec or <110 msec 3. Evidence of second or third-degree AVB 4. Electrocardiographic evidence of complete LBBB, complete RBBB or incomplete LBBB 5. Intraventricular conduction delay with QRS duration >120 msec 6. Heart rate <40 bpm or >90 bpm 7. Pathological Q waves (defined as >40 msec or depth >0.4-0.5 mV) 8. Evidence of ventricular pre-excitation 9. The safety laboratory analyses at Screening are outside the normal limits and considered by the Investigator as clinically significant. 10. Any acute or chronic condition that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study, a history of noncompliance to medical regimens, or subjects who are considered to be potentially unreliable. 1. The subject has a positive test result for HIV antibody. 2. The subject has a positive test result for the hepatitis C antibody or the HBsAg
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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): 40.0-65.0, Adult Lymphoblastic Lymphoma Disease ALL in complete remission (CR) at the time of transplant. Remission is defined as "less than 5.0% bone marrow lymphoblasts by morphology," as determined by a bone marrow aspirate obtained within 2 weeks of study registration Philadelphia chromosome positive ALL is allowed Lymphoid blastic crisis of CML will be included (provided that patients achieve CR) Age Equal or above age 40 and up to 65 years. If younger than 40, there must be comorbidities which preclude the patient to undergo CyTBI conditioning regimen Organ Function All organ function testing should be done within 28 days of study registration Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity) ≥ 50% predicted, DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for hemoglobin) ≥ 50% of predicted Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula: CrCl = (140-age) x weight (kg) x 0.85 (if female)/72 x serum creatinine (mg/dL) Hepatic Non-compliant to medications No appropriate caregivers identified HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive Active life-threatening cancer requiring treatment other than ALL Uncontrolled medical or psychiatric disorders Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest CT scan within 14 days of registration Active central nervous system (CNS) leukemia Preceding allogeneic HSCT Receiving intensive chemotherapy within 21 days of registration. Maintenance type of chemotherapy will be allowed
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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, Breast Cancer Nos Metastatic Recurrent Women Aged 18 years and over With an invasive breast cancer diagnosed by cytology or histology Tumors cT0 to cT3, CN0-3 No clinical evidence of metastasis at the time of Untreated including scored for breast cancer surgery in progress Patient receiving a social security system Patient mastering the French language Free and informed consent for additional biological samples, different questionnaires and collecting information on resource usage Metastatic breast cancer Local recurrence of breast cancer History of cancer within 5 years prior to entry into the trial other than basal cell skin or carcinoma in situ of the cervix Already received treatment for breast cancer ongoing Blood transfusion performed for less than six months Persons deprived of liberty or under supervision (including guardianship)
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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, Thyroid Cancer Newly diagnosed with a first occurrence of thyroid cancer <2-4 weeks of diagnosis (i.e., histologically confirmed thyroid cancer (papillary, follicular, or medullary type; TNM classification system) Willing to participate in the EG meetings >18 years Alert and capable of giving free and informed consent Able to speak and read English or French Anaplastic thyroid cancer Karnofsky Performance Status (KPS) score <60 (rated by the Research Coordinator (RC) or referring physician) or expected survival <6 months according to clinical judgment
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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): 18.0-65.0, Chronic Pain Women Clinical diagnosis of chronic pelvic pain More than eighteen years Non-menstrual or noncyclic pelvic pain Duration of pain of at least 6 months Duration of pain less than 6 months Women who were pregnant in the last 12 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, Coronary Artery Stenosis Age ≥ 18 years Patient with an indication for PCI including angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), or recent STEMI. For STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be >24 hours prior to randomization and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked Non-target vessel PCI are allowed prior to randomization depending on the time interval and conditions as follows: a. During Baseline Procedure: i. PCI of non-target vessels performed during the baseline procedure itself immediately prior to randomization if successful and uncomplicated defined as: <50% visually estimated residual diameter stenosis, TIMI Grade 3 flow, no dissection ≥ NHLBI type C, no perforation, no persistent ST segment changes, no prolonged chest pain, no TIMI major or BARC type 3 bleeding. b. Less than 24 hours prior to Baseline Procedure: i. Not allowed (see #3). c. 24 hours-30 days prior to Baseline Procedure: i. PCI of non-target vessels 24 hours to 30 days prior to randomization if successful and uncomplicated as defined above. ii. In addition, in cases where non-target lesion PCI has occurred 24-72 hours prior to the baseline procedure, at least 2 sets of cardiac biomarkers must be drawn at least 6 and 12 hours after the non-target vessel PCI. If cardiac biomarkers are initially elevated above the local laboratory upper limit of normal, serial measurements must demonstrate that the biomarkers are falling. d. Over 30 days prior to Baseline Procedure: iii. PCI of non-target vessels performed greater than 30 days prior to procedure whether or not successful and uncomplicated Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule. Angiographic (visual estimate) Treatment of up to three de novo target lesions, maximum of one de novo target lesion per vessel Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm and diameter stenosis ≥50% to <100% Lesion must be ≤28 mm long and can be covered by a single study stent with maximum length of 33 mm (note: multiple focal stenoses may be considered as a single lesion and be enrolled if they can be completely covered with one stent) TIMI flow 2 or 3 If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria Planned procedures after the baseline procedure in either the target or non-target vessels STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital or in whom enzyme levels (either CK-MB or Troponin)have not peaked PCI within the 24 hours preceding the baseline procedure and randomization Non-target lesion PCI in the target vessel within 12 months of the baseline procedure History of stent thrombosis Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP Known LVEF <30% Subject is intubated Relative or absolute contraindication to DAPT for 12 months (including planned surgeries that cannot be delayed, or subject is indicated for chronic oral anticoagulant treatment) Hemoglobin <10 g/dL
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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, Arrhythmia, Palpitations, Lightheadedness Patients >18 years of age with symptoms such as palpitations or pre-syncope suggestive of arrhythmias (usually occurring less frequently than once a day) with prior non-diagnostic ECGs and/or Holter monitoring. Patients who own an iPhone 4, 4S or 5 device and demonstrate the capability of recording and uploading a test ECG recording at the office visit Patients <18 years of age. 2. Patients with a myocardial infarction (MI) within the last three months, and/or known history of sustained VT/VF. 3. Patients with NYHA class IV heart failure. 4. Patients with unstable angina. 5. Patients with syncope as the presenting symptom. 6. Patients unable to or unwilling to use the device
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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, Neurocardiogenic Syncope Vasovagal Syncope Subject is able and willing to sign and date the Patient Consent Form Subject is 18 years of age or older Subject is expected to remain available for the follow-up protocol Subject is willing to comply with the follow-up procedures Subject has medically documented history of neurocardiogenic syncope Subject has had 3 episodes of syncope or presyncope in last 12 months Subject has had a positive tilt table test, defined as the presence of syncope or presyncope associated with abrupt hypotension (SBP < 70 mmHg) or bradycardia (HR < 40 bpm), with or without sublingual nitroglycerin provocation or atropine challenge Subject has been tried on at least one pharmacologic therapy for at least 4 weeks Subject has signs and symptoms of an active infection (i.e. fever, elevated white blood cell count, etc.) which has not been treated and/or has not demonstrated improvement in white blood cell count and resolution of fever Subject is pregnant or planning to become pregnant within the study protocol follow-up Subject is enrolled or planning to participate in a concurrent drug and/or device study during the course of this study that would confound study results as determined by the study physician Subject is unwillingly to comply with the randomization procedure Subject has had no syncopal episodes in last six months while on medical therapy Subject has one of the following conditions that is the documented source of syncope: sick sinus syndrome, sinus node or atrioventricular conduction deficiencies, ventricular tachyarrhythmias, pulmonary hypertension, hypertrophic cardiomyopathy, history of transient ischemic attack, seizure disorders, subclavian steal syndrome, or drug-induced syncope Subjects with a myocardial infarction within last six months Subjects with severe heart failure (NYHA class III or IV), previous heart surgery, structural heart disease, or an infiltrative cardiac disease Subject is contraindicated for left-atrial ablation, as determined by enrolling physician
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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, Blood Pressure Depression Panic Attack Fibromyalgia POTS Inappropriate Sinus Tachycardia Coronary Heart Disease Acute Coronary Syndrome (ACS) Acute Myocardial Infarction (AMI) Cerebrovascular Disease (CVD) Transient Ischemic Attack (TIA) Atrial Fibrillation Diabetes Mellitus Cancer Systolic Heart Failure Diastolic Heart Failure Chronic Fatigue Syndrome Syncope Vasovagal Syncope Any patient regardless of the age of gender Any non-correctable secondary cause of increase or decrease in blood pressure or a pathology that alters the prognosis before the entrance of the patient into this registry nephropathy prior to the admission familial dyslipidemia previous gastric bypass pre-existing heart failure chemotherapy-induced cardiotoxicity arrhythmogenic right ventricular dysplasia long QT syndrome hypertrophic cardiomyopathy
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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, Bradycardia Subject must have one of the clinical indications before device implant in adherence with Medicare, ACC/AHA/HRS/ESC single chamber pacing guidelines including Chronic and/or permanent atrial fibrillation with 2 or 3° AV or bifascicular bundle branch block (BBB block), including slow ventricular rates (with or without medication) associated with atrial fibrillation; or 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 Sinus bradycardia with infrequent pauses or unexplained syncope with EP findings; and 2. Subject ≥18 years of age; and 3. Subject has life expectancy of at least one year; and 4. Subject is not enrolled in another clinical investigation; and 5. Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and 6. Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the IRB; and 7. Subject is not pregnant and does not plan to get pregnant during the course of the study Subject has pacemaker syndrome, has retrograde VA conduction or suffers a drop in arterial blood pressure with the onset of ventricular pacing; or 2. Subject is allergic or hypersensitive to <1 mg of dexamethasone sodium phosphate; or 3. Subject has a mechanical tricuspid valve prosthesis; or 4. Subject has a pre-existing endocardial pacing or defibrillation leads; or 5. Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT); or 6. Subject has an implanted vena cava filter; or 7. Subject has evidence of thrombosis in one of the veins used for access during the procedure; or 8. Subject has an implanted leadless cardiac pacemaker; or 9. Subject had recent cardiovascular or peripheral vascular surgery within 30 days 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, Syncope Presyncope Palpitations 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 dermatitis or infected skin over the sternum (Carnation patch) or left upper anterior thorax (Zio patch) A sternal or thoracic incision that extends under the patch 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, Indications for VVI(R) Pacemaker Subject must have one of the following clinical indications: Chronic atrial fibrillation with 2 or 3° AV or bifascicular bundle branch block (BBB block) ; or Normal sinus rhythm with 2º or 3° AV or BBB block and a low level of physical activity or short expected lifespan (but at least one year); or Sinus bradycardia with infrequent pauses or unexplained syncope with EP findings; and Subject ≥18 years of age; and Subject has life expectancy of at least one year and is a suitable candidate based on overall health and well-being; and Subject is not enrolled in another clinical investigation with a treatment arm or that could confound the results of this study; and Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the EC; and Subject is not pregnant and does not plan on getting pregnant during the course of the study Known pacemaker syndrome, have retrograde VA conduction or suffer a drop in arterial blood pressure with the onset of ventricular pacing; or Hypersensitivity to < 1 mg of dexamethasone sodium phosphate; or Mechanical tricuspid valve prosthesis; or Pre-existing pulmonary arterial (PA) hypertension (PA systolic pressure exceeds 40mmHg or RV systolic pressure (RVSP) as estimated by echo exceeds 40mmHg) or significant physiologically-impairing lung disease (has severe pulmonary disease producing frequent hospitalization for respiratory distress or requiring continuous home oxygen); or Pre-existing ventricular pacing or defibrillation leads; or Current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT); or Presence of implanted vena cava filter; or Evidence of thrombosis in one of the veins used for access during the procedure; or Cardiovascular or peripheral vascular surgery/intervention within 30 days of enrolment; or Presence of implanted leadless cardiac pacemaker
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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 Cardiomyopathy Age ≥ 18 years Ischemic cardiomyopathy NYHA II-III Recurrent ventricular tachycardia, ICD interventions (shock or ATP) Obtained written informed consent Age <18 years Previous VT ablation NYHA IV Cardiopulmonary decompensation within the last 4 weeks Pregnant women or women of childbearing potential without a negative pregnancy test within 48 hours prior to treatment History of hemorrhagic diathesis or other coagulopathies Contraindication for oral anticoagulation Hyper or hypothyroidism Drug or chronic alcohol abuse
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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 Patients with indication for ventricular tachycardia substrate ablation Pregnant woman Reduced expectancy of life (less than 12 months) Patient participating in another clinical study that investigates a drug or device Psychologically unstable patient or denies to give informed consent Any cause that contraindicate ablation procedure or antiarrhythmic drug
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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, Sudden Cardiac Arrest Ventricular Arrythmia Subject has a Class I indication for implantation of an ICD according to the American College of Cardiology (ACC)/American Heart Association(AHA)/Heart Rhythm Society (HRS) or European Society of Cardiology (ESC) Guidelines Subject (or subject's legally authorized representative) is willing and able to sign and date the Patient Informed Consent Form Subject is ≤ 18 years of age Subject with any as required by local law (e.g., age, pregnancy, breast feeding) Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the Medtronic Clinical Trial Leader Subject has any contraindication for ICD/CRT-D
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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): 18.0-80.0, Ventricular Arrhythmia Key Have an ICD or CRT-D implanted for primary or secondary prevention and at least one ICD intervention for ventricular tachycardia/ventricular fibrillation (VT/VF) [shock or ATP] within 60 days prior to screening or a documented VT/VF episode (prior to implantation) within 60 days prior to screening Use of highly effective contraception methods if female of childbearing potential or sexually active male Must be hemodynamically stable Key New York Heart Association (NYHA) Class IV heart failure Myocardial infarction, unstable angina, coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI) within 4 weeks prior to screening or during the screening period before randomization Hemodynamically significant primary obstructive valvular disease History of congenital heart disease Inherited arrhythmia such as Brugada syndrome. Individuals with long QT syndrome Type 3 (LQT-3) or hypertrophic cardiomyopathy (HCM) may be considered Individuals who are being considered for cardiac transplantation and are on a cardiac transplant list History of seizures or epilepsy Cardiac ablation within 3 months prior to screening or planned cardiac ablation during the study Severe renal impairment Abnormal liver function tests
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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): 18.0-85.0, Ventricular Tachycardia Ventricular Arrhythmia ≥ 18 and ≤ 85 years old Able to provide informed consent AICD implanted for primary prophylaxis against sudden cardiac death AICD implanted for secondary prophylaxis against spontaneous or inducible sustained VT without any reversible causes CAD with prior myocardial infarction (>60 days prior to enrollment) AICD or ECG documentation of ventricular arrhythmia responsible for appropriate AICD therapy (> 3 ATP or ≥ 1 appropriate Shock) Contraindication or allergy to contrast media, routine procedural medications or catheter materials Contraindication to an interventional procedure Current or previous (within 3 months) antiarrhythmic therapy Absolute contraindication to amiodarone or other AAD New York Heart Association (NYHA) functional class IV Stroke within the past 90 days Unstable angina Hypertrophic cardiomyopathy, Non-ischemic dilated cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia, Brugada Syndrome, Catecholamine sensitive polymorphic VT or long QT syndrome Subjects with active ischemia that are eligible for revascularization Life expectancy less than 6 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, Syncope Presyncope Palpitations 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 dermatitis or infected skin over the sternum (Carnation patch) or left upper anterior thorax (Zio patch) A sternal or thoracic incision that extends under the patch 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): 40.0-80.0, Endothelial Dysfunction FMD IMT Microcirculation Oxygen Pressure Carbon Dioxide Pressure Oxygen Saturation Forced Expiratory Volume After 1 Second stable coronary artery disease stable chronic obstructive pulmonary disease acute myocardial infarction within 30 days acute exacerbated COPD within 30 days acute infections severe acute or chronic renal failure severe heart failure atrial fibrillation severe cardiac arrhythmia hypotension active malignant disease active rheumatic disease
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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): 18.0-75.0, Monomorphic Ventricular Tachycardia Patient is receiving a new St.Jude Medical (SJM) Implantable Cardioverter Defibrillator (ICD) or SJM Cardiac Resynchronization Therapy-Defibrillator (CRT-D) implant, which has study required programing capabilities and is appropriate for remote monitoring. Subjects who have received the ICD / CRT-D up to 90 days prior to enrollment are also eligible Patient who has a high risk of ICD shock as shown by at least one documented Monomorphic VT (MMVT)** by one or more of the following: Spontaneous MMVT or Inducible MMVT during electrophysiology (EP) Study or Inducible MMVT during Non-Invasive Programmed Stimulation (NIPS) Study to 75 years of age 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 Note Pleiomorphic ventricular tachycardia (VT) (multiple MMVT morphologies) is acceptable but polymorphic VT or ventricular fibrillation (VF) is not Any history of stroke S-T elevation myocardial infarction (MI) or previous cardiac surgery within 60 days prior to enrollment Patient is pregnant or nursing Patient has New York Heart Association (NYHA) class IV heart failure Patient has incessant ventricular tachycardia (VT) necessitating immediate treatment (Patients with Incessant VT have continuous sustained VTs that recur promptly despite repeated intervention for termination over several (≥3) hours) Patient has VT/VF thought to be from channelopathies Limited life expectancy (less than one year) according to Investigator Patient has current class IV angina Recent coronary artery bypass graft (CABG < 60 days) or percutaneous coronary intervention (PCI < 30 days) Patient is currently participating in another investigational drug or device 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, Hypotensive Syncope Patients assuming chronic (>1 year) vasoactive therapy affected by reflex recurrent (>2 episodes) syncopes who have a positive dominant vasodepressor or mixed response to tilt table test and/or carotid sinus massage Orthostatic hypotension defined as fall in systolic blood pressure >20 mmHg during the first 3 minutes of active standing 2. Competing diagnosis of syncope different from hypotensive reflex syncope 3. Reflex syncope with negative response to carotid sinus massage and tilt table test 4. Cardioinhibitory reflex syncope which requires permanent cardiac pacing 5. Severe hypertension which requires treatment (>150/95) 6. Structured heart disease which requires hypotensive therapy in order to prevent acute heart failure 7. Cardiac hypotensive therapy in order to prevent recurrences 8. Previous stroke or transient ischemic attacks
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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, Stroke Transient Ischemic Attacks Intracranial Hemorrhage Atrial Fibrillation All patients aged 18 or over, hospitalized or having emergency unit visit during the study period because of thromboembolic event (stroke, TIA) or intracranial hemorrhage and having the diagnosis of atrial fibrillation
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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, Kidney Transplantation Kidney transplant patient for whom renal biopsies are stored in the "collection of the University Hospital Toulouse" (collection N° DC-2009-989) and who received information on the purpose of the study, use of biopsies and who has not manifested any opposition Kidney transplant patient with iterative biopsies with at least: post-surgery biopsy D0 (or early post-transplant biopsy D7 and at least one biopsy protocol Age> 18 years Case group Kidney transplant patient, followed up by "organ transplant unity" of CHU Toulouse, with antecedent of CMR progressing to CTG between 2006 and 2013. Control group Kidney transplant patient, followed up by "organ transplant unity" of CHU Toulouse, with antecedent of CMR without progressing to CTG between 2006 and 2013 patient with uncontrolled hypertension patient with diabetes mellitus - patient treated or who was treated with mTOR inhibitor recurrence of the initial glomerular pathology de novo glomerulopathy patient including in another study with an period still going
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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, Persistent Atrial Fibrillation All patients included in the registry and who have symptomatic persistent atrial fibrillation presenting to the institution who favor ablation as first line therapy instead of antiarrhythmics All patients with symptomatic persistent atrial fibrillation who have failed antiarrhythmic therapy Patients refusing follow up by event monitor 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): 18.0-999.0, Syncope Age≥18 2. Experienced a syncopal event within the past 48 hours 3. Either one of the following profiles(A or B) apply: A. ED workup indicates that the patient may have experienced syncope that is cardiac in nature (any one or more of the following apply History or diagnosis of structural heart disease History of cardiovascular disease Age ≥ 40 Palpitations experienced pre-syncope Major ECG abnormalities QRS-duration greater than 140 ms PR-interval greater than 200 ms Non-specific repolarization abnormality Syncope experienced without any warning Clear diagnosis of non-cardiac syncope (e.g. orthostatic hypotensive syncope, vasovagal syncope, carotid sinus syncope, situational fainting) 2. An active implantable cardioverter-defibrillator (ICD) 3. An active unipolar pacemaker 4. Significant risk or suffering a cardiovascular event such as Symptoms of New York Heart Association (NYHA) class III or IV heart failure ED diagnosis of acute coronary syndrome Having required resuscitation in response to the index syncopal event Advanced directive prohibiting resuscitation (DNR) 6. Physical or mental conditions preventing subjects from interacting with or wearing the device as determined by the investigating physician. 7. Bandages or other clinical condition preventing SWD 1000 use 8. Injuries or other conditions beyond simple syncope that require hospitalization 9. Travel out of town during the study participation period that prevents the field service representative from visiting the subject daily 10. Unable or unwilling to provide 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): 0.0-999.0, Human Papillomavirus Parenting adult of adolescent age 11-17 years Adolescent received 1st dose of HPV at a study site within the last 2 weeks Eligible parent's cell phone has text message capability Language other than English or Spanish only Parent already in the study Intends to move away from the New York City area in <12 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): 0.083-999.0, Pulmonary Arterial Hypertension of Congenital Heart Disease The patient has a congenital heart disease other than patent foramen ovale The diagnosis of pulmonary hypertension was confirmed by cardiac catheterization. Only patients with Eisenmenger syndrome can be included without catheterization The catheterization was done after 1 January 2009 A mean pulmonary artery pressure > 25 mm Hg Pulmonary vascular resistances > 3 piece Wood m2 Pulmonary capillary pressure available Consent for in the study must be signed by parents or legal guardians for minors, by the patient for adults The patient he had a surgical procedure or interventional catheterization cardiac catheterization between his diagnosis and in the observatory? If yes, it can only be included if a new catheterization confirmed the persistence of HTAP at least 6 months after the procedure Patient follow-up (at least once a year) in the center for its HTAP associated with congenital heart disease its
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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, Sustained Monomorphic Ventricular Tachycardia Age 18 years or older Clinical indication for RF catheter ablation Presence of an implanted ICD At least 1 episode of spontaneous sustained monomorphic VT documented with ICD electrogram Presence of structural heart disease Able to obtain signed informed consent and willing to comply with study activity requirements It is anticipated that data can not be obtained during follow-up Unwilling or unable to provide informed consent Women who are or may potentially be pregnant Patients who are participating in another clinical trial
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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, Pulmonary Arterial Hypertension Evidence of a personally signed and dated informed consent document Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures and is deemed an appropriate candidate for participation in a long-term extension study and administration of APD811 Fulfilled all for APD811-003 and completed the study as planned Patients who discontinued for clinical worsening in APD811-003 and were assigned to placebo and completed all end of study procedures including right heart catheterization (RHC) may participate after their data from the APD811-003 study is cleaned and locked Patients who enrolled in APD811-003 and were withdrawn from study drug treatment due to any AE, SAE, or clinical worsening if assigned to APD811, or patients who did not complete the APD811 003 study for other reasons Female patients who wish to become pregnant Systolic BP <90 mmHg at Baseline/Day 1 Other severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into 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): 18.0-75.0, Postural Orthostatic Tachycardia Syndrome Non-smoking patients who qualify with the of idiopathic postural tachycardia syndrome will be studied. The are: 1. an increase of heart rate of 30 beats/minute or an upright heart rate of >= 120 bpm, and 2. chronic problems of symptoms during upright posture for at least 6 month Subjects must also be able to safely withdrawn from medications that influence heart rate, blood pressure, and hormone levels that regulate blood pressure The age limit is 18-75 years Patients that have other major medical problems, such as cancer or heart disease are excluded because the influence of that diagnosis on the symptoms is not known Pregnancy
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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): 18.0-85.0, Ventricular Tachycardia ≥ 18 and ≤ 85 years of age History of a remote MI (≥1 month) Survival of a ventricular arrhythmic event (VT/VF) that would mandate placement of an implantable cardioverter-defibrillator (ICD) (Patients who experience a ventricular arrhythmic event (VT/VF) while already being treated with Amiodarone (100-200 mg/day) are not excluded from the study. This is permitted provided that the patient had been treated with Amiodarone for at least 2 months prior to experiencing the index VT/VF event. These patients are randomized to either a higher dose of Amiodarone (e.g., 100mg/day -> 200mg/day or 200mg/day -> 400mg/day) or a higher dose of Amiodarone plus catheter ablation.) Patient cannot afford an ICD and thus has been planned for treatment with Amiodarone (or an increased dose of Amiodarone) Ability to understand the requirements of the study Willingness to adhere to study restrictions and comply with all post procedural follow-up requirements Patients with NYHA class IV congestive heart failure Prior ablation for a ventricular arrhythmia Presence of an LV thrombus Contraindication to anticoagulation Inability to access the endocardium because of mechanical mitral and aortic valve Life expectance <1 year for any medical condition
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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, MRI Scans Magnetic Resonance Imaging Pacemaker Implantable Cardioverter Defibrillator Patient has a non-MRI conditional permanently implanted pacemaker or ICD implanted after 2001 2. Patient has a strong clinical indication for MRI where MRI is the diagnostic modality of choice for specific disease state without acceptable alternative imaging technologies as determined by the ordering physician and a radiologist 3. Patient is at least 18 years of age 4. Patient is willing and able to sign study informed consent and HIPAA authorization Non-device related contraindication for MRI (such as implanted metallic objects, claustrophobia, morbid obesity) 2. Presence of capped/abandoned/epicardial leads or subcutaneous coil 3. Pregnancy 4. Device generator at elective replacement interval 5. Abdominal device implant
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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 clinical diagnosis of reflex syncope who meet all the following age >=40 years significant limitation of social and working life due to unpredictable or frequent syncope recurrences, ≥2 within the last year type 2B cardio-inhibitory response to TT (according to the VASIS classification) Alternative therapies have failed or were not feasible of other possible competitive causes of syncope Any other indication to IPG, implantable defibrillator (ICD), cardiac resynchronization therapy (CRT), according to current guidelines Any cardiac dysfunctions possibly leading to loss of consciousness overt heart failure ejection fraction (LVEF) <40% (Echo-assessed within 3-month prior to study participation) myocardial infarction diagnosis of hypertrophic or dilated cardiomyopathy clinically significant valvular disease sinus bradycardia <50 bpm or sinoatrial block Mobitz I second-degree atrioventricular block Mobitz II second or third-degree atrioventricular block bundle-branch block
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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 Patients with documented diagnosis of AF in the last six months by 12-lead electrocardiogram, rhythm strip, or Holter monitoring, pacemaker minimum 30 seconds (with or without treatment and regardless of rhythm during enrollment) Patients presenting AF (diagnosed by standard ECG or Holter monitoring) at baseline Patients should be eligible for treatment with oral anticoagulant thromboprophylaxis Patients with at least 1 risk factor for thromboembolism (CVE or outside the CNS) according to CHA2DS2VASc AF of transient causes (thyrotoxicosis, alcohol intoxication, myocardial infarction (MI) acute phase, pericarditis, myocarditis, electrocution, pulmonary embolism or other lung disease, electrolyte or metabolic disorder,etc) AF onset in immediate postoperative or 3 months in cardiac surgery Terminal illness Mental Inability to take anticoagulants Inability to fulfill the follow-up visits Programming for ablation of pulmonary veins Pregnant or lactating 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): 18.0-999.0, Brugada Syndrome S-ICD System (Implantable Defibrillator) Patient with type I Brugada syndrome eligible for implantation of an S-ICD system: Symptomatic : (history of resuscitated sudden death, syncope) with an ECG showing an aspect of Brugada syndrome type I before or after pharmacological tests (ajmaline or flecainide test) according to the of the consensus conference and after ECG validation by the Clinical Events Committee experts. Asymptomatic: with an aspect of spontaneous type I Brugada syndrome after ECG validation by the Clinical Events Committee experts Brugada syndrome patient with Indication for ICD replacement No contra-indication for S-ICD implantation (anatomic or physiologic criteria) with particular attention to the validation of the ECG prescreening implantation. For this study at least 2 vectors must be suitable for S-ICD implantation Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law Patients who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center Incessant ventricular tachycardia (VT) and/or documented spontaneous, frequently recurring VT that is reliably terminated with anti-tachycardia pacing Patients with unipolar pacemakers or implanted devices that revert to unipolar pacing Presence of any severe medical condition such that the patient is not expected to survive for the planned study follow-up period Minor, patient under trusteeship or under guardianship Patients who currently participate in an investigational drug or device that clinically interferes with the S-ICD-Brugada registry study endpoints and results Female of childbearing potential without adequate contraception at the time of the implantation Inability to comply with the follow-up schedule
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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): 2.0-999.0, Lysosomal Acid Lipase Deficiency Non-obese** patients with elevated low-density lipoprotein (LDL) 2. Non-obese** patients with low high-density lipoprotein (HDL) 3. Non-obese** patients with unexplained and persistently elevated liver transaminases, 4. Non-obese** patients with hepatomegaly 5. Patients with cryptogenic cirrhosis 6. Patients with biopsy-proven microvesicular or mixed micro/macrovesicular steatosis without a known etiology 7. Patients with presumed Familial Hypercholesterolemia (FH) in which genetic analysis was performed for the genes encoding the low-density lipoprotein receptor (LDLR), Apo-B and PCSK9 genes and no disease-causing mutations were identified 8. Patients with presumed FH with unclear family history 9. Patients with autosomal recessive hypercholesterolemia (other than homozygous FH) 10. Patients with autosomal recessive low HDL of unknown etiology Also, patient must meet the following Patient or patient's parent or legal guardian (if applicable) consents to participate in the study and provides informed consent prior to any study procedures being performed. If the patient is of minor age; he/she is willing to provide assent where required per local regulations, and if deemed able to do so Patient is willing and able to comply with protocol requirements Patients who do not fall into one of the aforementioned categories (cohorts) but are considered highly suspicious for LAL D should be tested to rule out the disorder outside of the study at the discretion of the Investigator Active viral hepatitis Other confirmed genetic liver diseases (e.g., Wilson's disease, hemochromatosis, alpha 1-antitrypsin)
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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 ≥ 18 years of age Patients of African, European, and Hispanic descent History of typical or early-onset symptomatic (≥2 episodes/month) paroxysmal/persistent AF ECG that was recorded within 1 month of randomization showing AF Eligible for both Flecainide(Class I) and Sotalol (Class III) AAD Able to give informed consent Permanent AF or isolated atrial flutter Cardiac or thoracic surgery within the previous 6 months Previous use of amiodarone other than short-term use (e.g. for an acute arrhythmia in hospital) Medical condition that is likely to be fatal in less than one year A history of prior AF ablation Have already been tried on 2 or more AADs in the past for AF Creatinine clearance <40 ml/min Left ventricular ejection fraction < 50% Contra-indication to a Class I AAD e.g., structural heart disease, or history of MI Contra-indication to a Class III AAD, e.g., congenital or acquired long QT syndrome with QTc>480 ms in females and >460 ms in males at baseline
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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, Non-valvular Atrial Fibrillation Diagnosis of non-valvular atrial fibrillation during hospitalization Preexisting atrial fibrillation Successful all-comer percutaneous coronary intervention: Procedural success is defined as a reduction of residual luminal diameter stenosis to <50% without in-hospital death, AMI or the need for emergency CABG Over 18 years of age Able to provide written informed consent Atrial fibrillation due to reversible causes (e.g., thyrotoxicosis, pericarditis) Valvular atrial fibrillation secondary to severe mitral stenosis or prosthetic heart valve Women who are of childbearing potential Treatment with other investigational drugs or devices within 30 days before enrolment or planned use of investigational drugs or devices during the study Life expectancy <12 months due to non-cardiac comorbidities Active alcohol, drug abuse, psychosocial reasons making study participation impractical Severe renal insufficiency (calculated creatinine clearance < 30 mL/min) or dialysis Clinically overt stroke within the last 3 months Known hypersensitivity or contraindication to aspirin, clopidogrel, prasugrel, ticagrelor, dabigatran, rivaroxaban, apixaban, edoxaban or warfarin
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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, Intraventricular Hemorrhage Age > 18 Coma at presentation (i.e. Glasgow Coma Score <9) At least 50% of lateral ventricles cast with blood Evidence of hydrocephalus or raised intracranial pressure and External Ventricular Drainage Indicated Surgery possible within 48 hours of ictus Fixed and dilated pupils at presentation Uncorrectable coagulopathy or thrombocytopenia Aneurysm or arteriovenous malformation proven or suspected as the source of haemorrhage Large, predominant intracerebral haematoma
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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, Stroke An individual is eligible for if all of the following apply: 1. Is 18-80 years old 2. Has had a recent (within the past 9 days), acute, cortical, hemispheric, ischemic stroke in the middle cerebral artery (MCA) distribution without a midline shift as detected by magnetic resonance imaging (MRI) as a diffusion-weighted image (DWI) abnormality 3. Has a National Institutes of Health Stroke Scale (NIHSS) score of 8-15 (R) and 8-18 (L) at the time of enrollment with no more than a 4 point increase (worsening of score) from the baseline score compared to 24 hours prior to infusion 4. Subjects must have a platelet count >100,000/uL, hemoglobin >8gm/dl, and white blood cell count (wbc) >2,500/uL. 5. Subjects who received tissue plasminogen activator (tPA) or underwent mechanical reperfusion may be included in the study. 6. Is able to provide consent to study or consent is obtained from the subject's legally authorized representative 7. Subjects of childbearing potential must practice effective contraception during the study, and be willing to continue contraception for at least 6 months after intervention so that, in the opinion of the investigator, they will not become pregnant during the course of the study 8. Is a good candidate for the trial, in the opinion of the investigator 9. Agrees to participate in follow up visits 10. Has an ABO/Rh matched umbilical cord blood unit with a minimum of 0.5 x 10^7 total nucleated cells (TNCC)/kg based on the pre-cryopreservation TNCC An individual is ineligible to participate if any of the following apply. Medical Conditions: 1. Has a medical history of neurological or orthopedic pathology with a deficit as a consequence that results in a modified Rankin Scale >1 before stroke or has a pre-existing cognitive deficit 2. Has clinically significant and/or symptomatic hemorrhage associated with stroke 3. Has new intracranial hemorrhage, edema, or mass effect that may place patient at increased risk for secondary deterioration when assessed prior to infusion 4. Has hypotension as defined as the need for IV pressor support of systolic blood pressure <90 5. Has isolated brain stem stroke 6. Has pure lacunar stroke 7. Requires mechanical ventilation 8. Requires a craniotomy 9. Has a serious psychiatric or neurological disease which could alter evaluation on functional or cognitive scales 10. Has an active systemic infection or is HIV positive 11. Has had an active malignancy within 3 years prior to the start of screening excluding skin cancers other than melanoma 12. Has known coagulopathy such as Factor V Leyden, AntiPhospholipid Syndrome (APC), Protein C, Protein S deficiency, sickle cell, anticardiolipin antibody, or phospholipid syndrome 13. Has any concurrent illness or condition that in the opinion of the investigator might interfere with treatment or evaluation of safety 14. Has current or recent history of alcohol or drug abuse, or stroke associated with drug abuse 15. Pregnant as documented by urine or blood test Concomitant or Prior Therapies: 1. Subjects currently receiving immunosuppressant drugs 2. History of prior transfusion reaction 3. Currently on dialysis 4. Recipient of bone marrow or organ transplant 5. Renal insufficiency with serum creatinine >2.0 mg/dL 6. Hepatic insufficiency (bilirubin >2.5mg/dL or transaminases >5x the upper limit of normal). Patients with Gilberts syndrome are eligible for study enrollment if other liver function tests are normal, regardless of bilirubin level. 7. Any previous or current treatment with angiogenic growth factors, cytokines, gene or stem cell therapy 8. Subjects participating in another interventional clinical trial of an investigational therapy within 30 days of screening Other: 1. Pregnant or lactating women 2. Unable to be evaluated for follow up visits
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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, Postpartum Hemorrhage A patient will be considered for in the study if she meets all of the following She has a term (≥37 completed weeks) live singleton gestation in cephalic presentation and has been admitted to the Labor and Delivery Unit She is in the latent phase of labor or has been admitted for induction of labor or at prenatal clinic visit She has had fewer than four prior vaginal deliveries She reports no allergy to misoprostol. The following factors or conditions will a patient from consideration as a subject The fetus has a known major fetal malformation or chromosome abnormality The gestation is multiple There is a breech or other malpresentation The patient reports involvement in another clinical trial currently or previously in this pregnancy The patient is expected to have a cesarean delivery
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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): 18.0-85.0, Inherited Cardiac Arrythmias Long QT Syndrome (LQTS) Brugada Syndrome (BrS) Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) Early Repolarization Syndrome (ERS) Arrhythmogenic Cardiomyopathy (AC, ARVD/C) Hypertrophic Cardiomyopathy (HCM) Dilated Cardiomyopathy (DCM) Muscular Dystrophies (Duchenne, Becker, Myotonic Dystrophy) Normal Control Subjects All patients and family members 18 years of age or older with inherited cardiac arrhythmias including LQTS, Brugada Syndrome (BrS), cathecholaminergic polymorphic ventricular tachycardia (CPVT) or early repolarization syndrome (ERS) are eligible for enrollment All enrolled patients will have undergone clinically indicated genetic testing Age <18 years >85 years pregnant women life-limiting co-morbidities immunocompromise
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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, Peripheral Nerve Disorder Associated With Repair of Hernia Male patients 18 years of age or older undergoing initial inguinal (bilateral or unilateral) hernia repair by any method (i.e. laparoscopic or open surgery) Age less than 18 years of age, recurrent hernias, emergency operations, already taking gabapentin, allergy to gabapentin, pre-existing chronic pain or psychiatric disorder
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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 Patients with VT and have an implanted ICD who are scheduled for VT catheter ablation Patients 18 years of age or older Patients with difficult airway management or patients with contra/ relative contra indication for general anesthesia or known allergies to any of the proposed anesthetic agents 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, Surgical Procedure, Unspecified All patients admitted to the Papworth Hospital NHS Foundation Trust for routine cardiovascular surgery and who are discharged from ICU into the study ward (Mallard) transplant surgery patients VAD patients children (less than 18 years old) prisoners (due to constant observation/security may bias normal level of care) patients who are subject to additional protections: this includes pregnant women, and persons with mental illness and learning disabilities patients whose anatomy precludes the use of the required monitoring patients who cannot understand written English (and where no translator is available) patients who are unable to give consent themselves patients with learning difficulties who cannot understand the information to consent for themselves
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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, Long qt Syndrome Torsade de Pointes For simplicity, we will plan to all possible cases of TdP meeting (see below) into the registry age <18 years old 2. inability to obtain informed consent from the patient or a family member 3. no on the basis of race or gender. torsade de pointes clinical syndrome according to one of the following three clinical 1. Definite TdP: At least 3 beats of polymorphic ventricular tachycardia (VT) or ventricular fibrillation (VF) on a 12-lead ECG or rhythm strip with documented QTc > 450 ms in men or QTc > 470 in women (excluding patients with conduction block or AF at baseline, see below) prior to arrhythmic event. 2. Probable TdP: At least 3 beats of polymorphic VT or VF on a 12-lead ECG or rhythm strip with QTc > 450ms (men) or 470ms (women) after the event, or polymorphic VT or VF episode not meeting for 'definite TdP' but determined by the adjudicating physician to be likely TdP. For patients having a cardiac arrest, at least 1 hour after restoration of normal rhythm or after secondary hypoxia or electrolyte abnormalities have been ruled out (confounders of QT prolongation often seen post-arrest47) will be required. 3. Possible TdP: Unexplained syncope in a patient presenting with QTc > 450ms (men) or 470ms (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): 0.0-999.0, Aortic Stenosis Heart Failure Syncope Angina Pectoris aortic stenosis detected by echocardiography / invasively acute coronary syndrome endocarditis
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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, Arrhythmias, Cardiac Care providers including the individuals responsible for monitoring patients (monitoring technicians and nurses), individuals communicating life threatening events (monitoring technicians, health unit coordinators, and nurses) and the individuals responsible for the initial check on a patient in the event of life-threatening cardiac arrhythmias (generally the patient's nurse) Patients for whom cardiac monitoring was ordered by their physician
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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, Resident Education and Assessment of Difficult and High Acuity Scenarios That Focus on Cardiac Anesthesia Resident physicians who have completed at least one month of cardiac rotation are included.This high fidelity simulation lab course if offerred to every resident that meets the criteria.This is a part of their educational activity.At the beginning of the course they are given the option to participate in the survey.If they do not wish to participate in the survey it will not affect their education.Participitaion in the survey is purely voluntary Resident physicians that did not wish to participate in filling out the survey or not able to fill out the survey
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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, Vasovagal Syncope or more syncopal spells in the year preceding enrolment More than -2 points on the Calgary Syncope Symptom Score Age ≥18 years with informed consent Other causes of syncope, such as ventricular tachycardia, complete heart block, orthostatic hypotension or hypersensitive carotid sinus syndrome Inability to give informed consent important valvular, coronary, myocardial or conduction abnormality or significant arrhythmia hypertrophic cardiomyopathy a permanent pacemaker a seizure disorder hypertension defined as >150/90 mm Hg pregnancy glaucoma medications with known effects on blood pressure
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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 Newly documented POAF of more than 5 minute duration cardiac surgery during index hospitalization, including (CABG, valvular replacement or repair, a combination) without Maze procedure CHA2DS2-VASc≥2 Sinus rhythm at the time of BioMonitor implantation or definite intention to cardiovert prior to discharge Signed Informed Consent History of atrial fibrillation/flutter prior to cardiac surgery Contraindication for anticoagulation therapy Dual chamber pacemaker or ICD implanted or planned Active systemic infection Another (non-AF) indication for long term anticoagulation Maze procedure Inability to attend scheduled, periodic office visits for follow-up Pregnancy
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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, Fasting Ability to give written informed consent 2. Diagnostic coronary angiography and coronary interventions (both elective and stable Acute Coronary Syndrome {ACS} patients). 3. ≥ 18 years of age Patients who are intubated 2. Patients unable to give informed consent 3. Patients presenting with an acute unstable condition, including: 1. STEMI 2. unstable ACS 4. Patients with a history of or at risk for aspiration pneumonia stroke dysphagia severe gastroesophageal reflux disease 5. Patients with known or anticipated difficult airway 6. Patients who request to be allotted to a particular arm of the study 7. Patients who are temporary transfers from other hospitals
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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, Monomorphic Ventricular Tachycardia Patient is receiving a new SJM ICD or CRT-D implant system, which has study required programing capabilities and is appropriate for remote monitoring. Patients who have received the ICD or CRT-D up to 30 days prior to enrollment are also eligible. Patient consents to have a NIPS/EP study. Patient has documented Ejection Fraction (EF) < 50% and / or Right Ventricular (RV) dysfunction. Patient has documented structural cardiomyopathy of any kind >1 month. Patient is between 18 to 75 years of age. Patient has been informed of the nature of the study and has agreed to its provisions and provided written informed consent using a form approved by the Institutional Review Board/Ethics Committee (IRB/EC) Patient has history of stroke. Patient has had ST Segment elevation myocardial infarction (MI); or previous cardiac surgery within 60 days prior to enrollment. Patient is pregnant or nursing. Patient has chronic New York Heart Association (NYHA) Class IV heart failure. Patient has limited life expectancy according to the investigator (less than one year). Patient has had a recent coronary artery bypass graft (CABG) (< 60 days) or percutaneous coronary intervention (PCI) (< 30 days). Patient is currently participating in an investigational drug or device study Patient is unable or unwilling to cooperate with the study procedures. Patient has a prosthetic mitral or aortic valve. Patient has mitral or aortic valvular heart disease requiring immediate surgical intervention. Patient has Left Ventricular EF < 15%. Patient has had a previous ablation procedure for ventricular tachycardia (VT), excluding remote (> 3 months) outflow tract tachycardia. Patient has previously documented history of severe loss of kidney function or kidney failure. Patient has premature ventricular contractions (PVC) or VT induced cardiomyopathy expected to resolve with ablation and will not require an ICD. Patient has reversible cause of VT
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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, Arrhythmia, Cardiac Patients with an implanted pacemaker/cardiac resynchronization therapy with a pacemaker(CRT-P) capable of remote patient management would be eligible for the study that will be followed by the site where the implantation occurred OR patients with an implanted defibrillator/CRT-D capable of remote patient management where the patients reside in a community of the site where the implantation occurred. The device may be de novo, existing or a patient undergoing a pulse generator change that now has remote patient management capabilities. 2. Able to provide 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, Out of Hospital Cardiac Arrest Glasgow Coma Scale score <8 on hospital admission following OHCA of presumed cardiac cause Initial rhythm ventricular tachycardia (VT) / ventricular fibrillation (VF), who achieved ROSC sustained for >20 consecutive minutes ST-elevation on any of the ECGs post resuscitation Hypothermia <30°C Interval from ROSC to screening of >12h Suspected or known acute intracranial hemorrhage or stroke
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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 Patients with syncope refered to perform 24-hours conventional Holter who fulfill at least one of the following conditions: 1. ≥2 episodes of syncope in the last year, provided that they are not typical vasovagal syncope, and/or 2. ≥1 episode of syncope with any criterion of suspicion of cardiac-arrhythmic aetiology, according to current European Guidelines about management of syncope Carrier of any cardiac implantable electronic device or internal loop recorder, as well as stablished indication for it according to current guidelines Aetiologic diagnosis of syncope already known Left ventricular ejection fraction ≤35% Unability to perform the monitorization
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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 Patients with diagnosis of stroke being discharged from the Neurology unit and/or the Neurology Acute Care Unit in the Civic Campus of TOH. 2. Patients presenting with overall mild to moderate communication deficits, And/or 3. Patients with score ≥ 1 on the best language and/or dysarthria parameters of the National Institute of Health Stroke Score (NIHSS) 4. Stroke Patients being discharged to their HOME/PRIMARY awaiting outpatient speech and language therapy services. And/or 5. Patients being discharged to their HOME/PRIMARY who would benefit from SLP therapy services but are unable to receive these secondary to various accessibility challenges (i.e. remote geographical location, limited service availability, transportation, unable to pay for SLP services). 6. Patients must have access to Wi-Fi connection at their HOME/PRIMARY Patients with pre-existing speech, language disorders or cognitive disorders (such as dementia). 2. Patients with severe debilitating disease(s) that, in the opinion, of the investigator will not be able to perform the required tasks of the study (ex: end-stage malignancy, ALS). 3. Patients with severe comprehension deficits 4. Patients not having access to Wi-Fi connection at HOME/PRIMARY 5. Patients who will be accessing the services of a private SLP while awaiting outpatient rehab
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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, Tachycardia, Ventricular subject has had an ICD previously implanted subject has drug-refractory monomorphic VT subject is a candidate for ischemic VT RF ablation subject has had a myocardial infarction subject has a LVEF less than or equal to 35% subject has non-ischemic VT subject has a history of stroke within 1 month prior to enrollment subject has had an acute myocardial infarction within 30 days prior to enrollment subject has unstable angina subject has undergone cardiac surgery within 60 days prior to enrollment subject is pregnant or nursing subject has a limited life expectancy of 1 year or less (Subjects requiring LVAD/IABP intraprocedural support may be enrolled as long as life expectancy is at least 1 year following the ablation procedure.) subject is unable or unwilling to cooperate with study procedures subject has a known presence of intracardiac thrombi as determined by echocardiography subject has a major contraindication to anticoagulation therapy or coagulation disorder
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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, Brugada Syndrome Patients affected by Brugada Syndrome, profiled by genetic testing, with documented spontaneous or drug-induced type I BrS ECG pattern, with symptoms attributable to ventricular arrhythmias and presenting multiple documented arrhythmic episodes Patients with an ICD already implanted Patients referred to the center for an electrophysiological study and indication to a potential concomitant radio-frequency catheter ablation (RFA) of ventricular arrhythmia or ventricular fibrillation Age ≥ 18 Willingness to attend follow-up examinations Written informed consent to the participation in the trial Pregnancy or breast-feeding Patients with low arrhythmic risk (Brugada pattern III) Life expectancy < 12 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): 15.0-999.0, Cardiac Rhythm Disorders Oral agreement of the patient or of the holder of parental responsibility after reading the informed consent form Patients with the following 3 conditions Ablation of drugs rebels arrhythmias Or implantation or programming of a pacemaker (pacemaker or defibrillator) Or symptoms and / or cardiopathy with risk of sudden death Pregnancy and lactation Patients unable to give oral agreement Inconsistent patient's morphology with the establishment of the electrode jacket
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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): 16.0-999.0, Syncope Patients aged 16 years or over presenting within 6 hours of an episode of syncope and whose syncope remains unexplained after ED assessment. Syncope will be defined as a transient loss of consciousness (TLOC) with inability to maintain postural tone and immediate complete spontaneous recovery without medical intervention (to preexisting mental status and neurologic function) Obvious underlying cause after ED assessment Alcohol or illicit drugs as presumptive cause of TLOC [24] Epileptic seizure as presumptive cause of TLOC (seizure activity with a >15 min witness reported post-ictal phase) [24] Stroke ⁄ transient ischemic attack as presumptive cause of TLOC [24] Head trauma followed by TLOC [24] Hypoglycemia as presumptive cause of TLOC [24] No consent i.e. patient lacking capacity Previous recruitment into the study Patient in custody or prison. Obvious underlying causes will be defined as Clinical history of vasovagal syncope i.e. pre-syncope symptoms and low-risk patient according to current ESC guidelines [14]
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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, Squamous Cell Carcinoma of the Head and Neck Written informed consent 2. Age ≥18 ≤ 80 years. 3. Performance Status ECOG 0-1 4. Histologically confirmed diagnosis of previously untreated locally advanced HNSCC (Stage III, IVa and IVb according to the American Joint Committee on Cancer Staging System) of one or more of the following sites: oral cavity, oropharynx, hypopharynx and larynx 5. Availability of pre-treatment tumour tissue (for biomarker analysis, PD -L1, TILs and immune-monitoring) 6. p16 expression from tumor sample (immunohistochemistry) 7. Recording of the smoking history 8. No viral infection (HIV, Hepatitis B/C) 9. No autoimmune disease 10. No immunodeficiency or immunosuppressive therapy 11. No active CNS disease 12. No interstitial lung disease 13. No active infection 14. Women of child-bearing potential: negative serum pregnancy test at screening and use of appropriate contraception methods from study entry 15. Patients not proposed cisplatin-based chemotherapy because of age, general condition, if medically unfit or patient refusal. 16. Adequate organ laboratory values 17. Health insurance coverage Nasopharyngeal, paranasal sinuses, nasal cavity tumours or thyroid cancers; 2. Squamous cell cancer involving cervical neck nodes with unknown primary site; 3. Metastatic disease; 4. Any prior or current treatment for invasive head and neck cancer. This will but is not limited to: prior tyrosine kinase inhibitors, any monoclonal antibody, prior neoadjuvant therapy, prior surgical resection, or use of any investigational agent; 5. Weight loss of >10% during the last 3 weeks prior the screening visit; 6. Concurrent treatment with any other systemic anti-cancer therapy that is not specified in the protocol; 7. Concomitant treatment with any drug on the prohibited medication list such as live vaccines (for details, see the protocol); 8. History of another malignancy within the last 3 years (exception of in situ carcinoma and skin carcinomas); 9. If female, pregnant or lactating; 10. Significant disease which, in the judgment of the investigator, as a result of the medical interview, physical examinations, or screening investigations would make the patient inappropriate for entry into the trial. 11. Known hypersensitivity reaction to study medication; 12. Any social, personal, medical and/or psychologic factor(s) that could interfere with the observance of the patient to the protocol and/or the follow-up and/or the signature of the 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, Atrial Fibrillation History of atrial fibrillation 2. Greater than or equal to 18 years of age 3. Scheduled to undergo an atrial fibrillation ablation procedure 4. Able to provide written informed consent 1. Long-standing persistent atrial fibrillation at the time of ablation (greater than 1 year of a continuous atrial fibrillation episode) 2. Is in atrial fibrillation or atrial flutter the morning of the ablation procedure 3. The presence of any of the following in a patient without a permanent pacemaker for implantable cardiac defibrillator 1. sick sinus syndrome indicated by the inability to previously tolerate an antiarrhythmic drug due to bradycardia 2. sinus bradycardia with a heart rate less than 50 beats per minute at the time of study drug administration 3. right bundle branch block, left bundle branch block, or bifascicular block 4. PR-interval > 280ms, or history of 2nd or 3rd degree atrioventricular block 4. Concomitant use of CYP3A4 and CYP2D6 inhibitors 5. Previous surgical or catheter ablation for atrial fibrillation or Cox-Maze procedure 6. Amiodarone use within 3 months prior to enrollment 7. Antiarrhythmic drug (other than amiodarone) within 5 half-lives prior to atrial fibrillation ablation 8. Expected life span < 1 year 9. Creatinine clearance <30 mL/min 10. Reversible cause of atrial fibrillation (ie. thyrotoxicosis) 11. Unrevascularized coronary artery disease 12. Canadian class IV angina 13. Left ventricular ejection fraction <40% 14. New York Heart Association Class III or IV symptoms 15. Previous heart transplantation 16. Planned heart transplantation or ventricular assist device 17. Cardiac/thoracic surgery <6 months prior to enrollment 18. Severe asthma or chronic obstructive pulmonary disease 19. 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): 18.0-999.0, Cancer of the Lung Lung Cancer Lung Neoplasms Adenocarcinoma of the Lung Non Small Cell Carcinoma of the Lung Small Cell Carcinoma of the Lung years of age or older, not previously diagnosed with cancer (except for basal cell carcinomas of the skin or a diagnosis of cancer within a month of surgery and for which the surgical procedure is being performed) Prior history of cancer
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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): 18.0-100.0, Acute Coronary Syndromes Heart Failure Pulmonary Edema Aortic Aneurysm, Familial Thoracic 1 Chest Pain Pulmonary Embolism Syncope all patients with acute coronary syndromes (ACS) or acute decompensated heart failure (ADHF) or warfarin intoxication or acute pulmonary edema or acute aortic dissection or chest pain or pulmonary embolism or syncope -There will be not
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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, Cystic Fibrosis Key Confirmed diagnosis of CF as determined by the 2008 Cystic Fibrosis Foundation Consensus Report Must have a body weight of > 40 kg (88.2 lb) at study screening Pre-bronchodilator FEV1 ≥ 40% and ≤ 80% of predicted at screening Two pre-bronchodilator spirometry measures during screening and baseline must meet the following 2 The relative difference of FEV1(L), calculated as the absolute value of [(first FEV1 second FEV1) / first FEV1] x 100 should be < 12% AND The absolute difference in FEV1 should be < 200 ml Negative Sputum Investigation/History of any Mycobacterium spp. or Burkholderia spp. per specified protocol-defined time periods Clinically stable with no evidence of significant respiratory symptoms that would require administration of IV antibiotics, oxygen supplementation, or hospitalization within 30 days of baseline Concurrent use of oral antibiotics (excluding chronic azithromycin use) or IV antibiotics within 30 days of baseline. Prophylactic and chronic doxycycline use is prohibited during the study Hospitalization for a respiratory event within 30 days of baseline Current use of systemic immunosuppressive drugs including oral corticosteroids within 30 days of Baseline Current requirement for daily continuous oxygen supplementation or requirement (medically necessary) of more than 2 L/minute at night (subject would not meet this criterion if supplemental oxygen is used for comfort only) History of solid organ (including lung) or hematologic transplant, or currently on a transplant waiting list Note: Other protocol defined Inclusion/
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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, Tachycardia Ventricular Arrhythmias Subject must be undergoing surgical procedure for approved indications for cardiothoracic surgery where a midline sternotomy is planned, or cardiothoracic surgery where a subxiphoid/paraxiphoid cut for a chest tube is planned, or VT ablation procedure with epicardial access, or implant of a subcutaneous ICD (S-ICD®), or implant of a transvenous ICD (single or dual chamber) Subject must be willing to provide Informed Consent Subject must be ≥ 18 years old Subject has known hiatus hernia or moderate or worse pectus excavatum Subject had previous pericarditis or prior sternotomy Subject has known significant Right Ventricle/ Right Ventricular dilation Subject has hypertrophic cardiomyopathy Subject is pacemaker dependent Subject has known skin irritations due to the Covidien Multi-function defibrillation electrode Subject is considered to be at high risk for infection(1) Subject has Left Ventricular Ejection Fraction < 20% (most recent available LVEF measurement in the last 6 months) Subject has New York Heart Association Class IV Subject has myocardial infarction within the last 6 weeks
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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): 18.0-89.0, Hip Labral Tears All patients who are undergoing a hip arthroscopy procedure at Northwestern Memorial Hospital with Dr. Michael Terry Pregnant women and any patient under the age of 18 years
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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, Heart Failure Myocardial Infarction Ventricular Tachycardia Post-MI patients eligible for ICD implantation in the setting of primary prevention NYHA IV or ambulatory NYHA IV 2. Acute coronary syndrome in the last 40 days 3. Stable angina not eligible to revascularization 4. Revascularization in the last 3 months (except MI) 5. Antiarrhythmic therapy other than b-blockers 6. LVEF<20% 7. GFR<30ml/min/1.73m2 8. Systematic illnesses
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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 patients evaluated in the Emergency Department for loss of consciousness identification of cause of loss of consciousness after initial evaluation loss of consciousness classified as high risk syncope
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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 Arrhythmia Adult (age ≥18 years) patients with syncope 2. High-risk as per the Canadian Syncope Arrhythmia Risk Score (score > or =3)and being discharged home after ED physician or consultant assessment Syncope patients with a score <3 2. Those who are hospitalized 3. Previously enrolled. 4. Loss of consciousness not related to syncope: prolonged loss of consciousness > 5 minutes 5. Change in the mental status from baseline 6. Patients with alcohol intoxication or illicit drug abuse, witnessed obvious seizure; or head trauma, i.e. trauma the initial event
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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, Aortic Valve Stenosis Age ≥18 years Moderate AS with AVA between 1-1.4cm2, and AVMG<40 millimetres of Mercury (mmHg); and Left Ventricular Ejection Fraction (LVEF) ≥50%; and Cardiac related symptoms; shortness of breath, chest pain or syncope Inability to exercise and undertake pharmacological stress, ie previously known intolerance to dobutamine Severe aortic or mitral regurgitation or severe mitral stenosis Significant pulmonary disease like severe (Chronic Obstructive Pulmonary Disease (COPD) or pulmonary fibrosis Atrial fibrillation Inability to provide informed consent Pregnancy Other known non-cardiovascular disease associated with poor prognosis like metastatic cancer
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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, Recurrent Ventricular Tachycardia Patients undergoing catheter ablation using the needle ablation catheter for ventricular arrhythmias Patient refusal to 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): 16.0-999.0, Signs and Symptoms Persons with palpitations and no clear cause who are above the age of 16 years and who consent to the study will be included 2. Clear causes that should be excluded are true arrhythmia such SVT or VT or frequent premature atrial or ventricular contractions or any organic cause such as thyroid disorder, anemia (hg less than 11 g/dl) and obvious anxiety disorder 3. Arrhythmia can be excluded by an ECG showing sinus rhythm or sinus tachycardia during episodes or measurement of heart rate by a reliable method during symptoms showing regular heart rate less than 120 beats per minute. 4. Patient will be randomized to either PPI or placebo to be taken one table at night time 5. Patients will be provided with 2 weeks supply but will be evaluated at 10 days to see if symptoms improved 6. The two groups will be compared using statistical methods to see if there is difference in improvement Refusal to participate or sign consent form Frequency of symptoms less than 2 times per week Already taking PPI or H2 blocker
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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 (VT) Prior Myocardial Infarction and One of the following VT events while not being treated with amiodarone, sotalol, or another class I or class III antiarrhythmic drug) within the last 6 months Sustained monomorphic VT documented on 12-lead ECG or rhythm strip terminated by pharmacologic means or DC cardioversion ≥3 episodes of VT treated with antitachycardia pacing (ATP), at least one of which was symptomatic ≥ 5 episodes of VT treated with antitachycardia pacing (ATP) regardless of symptoms ≥1 appropriate ICD shocks ≥3 VT episodes within 24 hours Unable or unwilling to provide informed consent Active ischemia (acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on ECG) or another reversible cause of VT (e.g. drug-induced arrhythmia), had recent acute coronary syndrome within 30 days, coronary revascularization (<90 days bypass surgery, <30 days percutaneous coronary intervention), or have CCS functional class IV angina. Note that biomarker level elevation alone after ventricular arrhythmias does not denote acute coronary syndrome or active ischemia Are ineligible to take the antiarrhythmic drug to which they would be assigned due to allergy, intolerance or contraindication Are known to have protruding left ventricular thrombus or mechanical aortic and mitral valves Have had a prior catheter ablation procedure for VT Are in renal failure (Creatinine clearance <15 mL/min), have NYHA Functional class IV heart failure, or a systemic illness likely to limit survival to <1 year Have had recent ST elevation myocardial infarction or non-ST elevation MI (< 30 days); note that biomarker elevation alone after ventricular arrhythmias does not denote MI Are pregnant
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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): 55.0-999.0, Subclinical Atrial Fibrillation Permanent pacemaker or defibrillator (with or without resynchronization) or insertable cardiac monitor At least one episode of device-detected SCAF ≥ 6 minutes in duration but no single episode > 24 hours in duration at any time prior to enrollment. Any atrial high rate episode with average > 175 beats/min will be considered as SCAF. No distinction will be made between atrial fibrillation and atrial flutter. SCAF requires electrogram confirmation (at least one episode) unless ≥ 6 hours in duration Age ≥ 55 years Risk Factor(s) for Stroke: Previous stroke, TIA or systemic arterial embolism OR Age at least 75 OR Age 65-74 with at least 2 other risk factors OR Age 55-64 with at least 3 other risk factors Other risk factors are Hypertension CHF Diabetes Vascular disease (i.e. CAD, PAD or Aortic Plaque) Female Must be from a participating Canadian recruitment centre Clinical atrial fibrillation documented by surface ECG (12 lead ECG, Telemetry, Holter) lasting ≥ 6 minutes, with or without clinical symptoms Mechanical valve prosthesis, recent (within past 6 months) deep vein thrombosis or pulmonary embolism or other condition requiring treatment with an anticoagulant Allergy to aspirin or apixaban Severe renal insufficiency (serum creatinine > 2.5 mg/dL [221 μmol/L] or a calculated creatinine clearance < 25 ml/min) Serious bleeding in the last 6 months or at high risk of bleeding (this includes, but is not limited to: prior intracranial hemorrhage, active peptic ulcer disease, clinically significant thrombocytopenia or anemia, recent stroke within past 10 days, documented hemorrhagic tendencies or blood dyscrasias) Moderate to severe hepatic impairment Ongoing need for combination therapy with aspirin and clopidogrel (or other combination of two platelet inhibitors) Meets for requiring lower dose of apixaban AND also has ongoing need for strong inhibitors of both CYP3A4 and P-glycoprotein (e.g., ketoconazole, itraconazole, ritonavir or clarithromycin) Ongoing need for strong inducers of both CYP3A4 and P-glycoprotein (e.g., rifampin, carbamazepine, phenytoin, St. John's wort) Received an investigational drug in the past 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): 18.0-999.0, Ventricular Tachycardia (VT) Patient is receiving a new implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy device (CRT-D) implant that has study required programing capabilities and is appropriate for remote monitoring. Patient who has received the ICD / CRT-D within 90 days of enrollment can also be enrolled Patient who has a high risk of ICD shock as shown by documented Monomorphic VT (MMVT) by one or more of the following Spontaneous MMVT Inducible MMVT during electrophysiology study Inducible MMVT during noninvasive programmed stimulation study *Inducible MMVT is defined as MMVT > 30 seconds or requiring electrical termination (ATP or cardioversion) Patient has ejection fraction < 50% or right ventricular dysfunction Patient has a cardiomyopathy with structural heart disease of any cause Any history of debilitating stroke with neurologic deficit ST-segment elevation myocardial infarction or previous cardiac surgery within 60 days prior to enrollment Patient is pregnant or nursing Patient has chronic New York Heart Association (NYHA) class IV heart failure Patient has incessant VT necessitating immediate treatment Patient has ventricular tachycardia/ventricular fibrillation thought to be from channelopathies Limited life expectancy (less than one year) Patient has current class IV angina Recent coronary artery bypass graft or percutaneous coronary intervention (< 45 days) Patient is currently participating in another investigational drug or device 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): 18.0-85.0, Arrhythmias, Cardiac The patient is willing and able to comply with the protocol and has provided written informed consent. 2. The patient falls within the target group as stated in 4.1. 3. Patient is an acceptable candidate for RDN treatment 4. Patient is 18-85 years of age 5. Documentation of ventricular arrhythmia (ECG, rhythm strip or ICD interrogation) Contraindication to anticoagulation therapy or heparin. 2. Previous selective cardiac sympathetic denervation or previous RDN procedure. 3. Acute coronary syndrome, cardiac surgery, PCI or stroke within 3 months prior to enrolment. 4. Untreated hypothyroidism or hyperthyroidism. 5. More than grade 1/3 valvular regurgitation and/or significant valve stenosis (moderate or severe). 6. Severe LV dysfunction (LVEF <20% and/or grade 3/4 diastolic dysfunction). 7. Enrolment in another investigational drug or device study. 8. Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertile age. 9. Mental or physical inability to participate in the study. 10. Planned cardiovascular intervention. 11. Life expectancy ≤ 12 months. 12. Renal artery stenosis >50% of the arterial lumen, or renal artery lumen ≤3 mm. 13. Complex renal 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, Syncope, Vasovagal ≥1 syncopal spells in the year preceding enrolment ≥-2 points on the Calgary Syncope Symptom Score Age ≥18 years with informed consent The Calgary Syncope Symptom Score is used to diagnose VVS in patients with structurally normal hearts Other causes of syncope, such as ventricular tachycardia, complete heart block, orthostatic hypotension or hypersensitive carotid sinus syndrome An inability to give informed consent Important valvular, coronary, myocardial or conduction abnormality or significant arrhythmia Hypertrophic cardiomyopathy Permanent pacemaker Seizure disorder Hypertension defined as >150/90 mm Hg Pregnancy Glaucoma Medications with known effects on blood pressure
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0
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