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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, Arrhythmias, Cardiac Tachycardia, Ventricular Ventricular Fibrillation Defibrillators, Implantable Diagnosis of ES (documentation of 3 or more episodes of sustained ventricular arrhythmia within 24h or documentation of sustained ventricular tachycardia lasted at least 12h).In order to fulfill this criterion, a patient with a previous episode of ES could also be enrolled during routine screening Age ≥18 Written informed consent patient without ICD Confirmed or suspected use of drugs or narcotics with known direct pro-arrhythmic effect Inability to express an informed consent for 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): 18.0-999.0, Ventricular Tachycardia Subjects with a history of ventricular tachycardia indicated for ventricular testing procedures that may VT induction, such as VT testing, VT ablation, VT mapping, or VT risk stratification testing Subjects age 18 or above, or of legal age to give written informed consent specific to local laws and requirements Subjects who, in the opinion of the investigator, are suitable to be enrolled in a clinical study Subjects with any comorbidities that, in the opinion of the investigator, would them from standard of care VT testing Subjects with VT that is known to be focal in nature Subjects whom the investigator believes are not hemodynamically stable enough to tolerate testing Subjects of childbearing age who may be pregnant Subjects who are unwilling or unable to provide written informed consent Subjects with any implanted device that emits electrical energy where either therapy cannot be temporarily disabled, or the subject cannot tolerate temporary disabling of therapy
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 40.0-999.0, Heart Failure Heart failure patients are included if They have their electronic medical records ("globaal medisch dossier") registered with one of the participating general practitioners They have a registered diagnosis of HF (ICPC-2 code K77 or free text) in their electronic health record (EHR). Patients can be included during the study if They give their informed consent to participate in the study Are eligible for a NT-proBNP POC test will be set
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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, Atrial Fibrillation Implantable Cardioverter Defibrillator Age 18 to 80 BMI 17 to 35 Proficient in English language Paroxysmal atrial fibrillation or ventricular fibrillation or frequent premature atrial/ventricular contractions No telephone access Active suicidal ideation with intent or plan Active drug or alcohol dependence, or active binge drinking within the last month Cardiovascular instability, as evidenced any of the following: 1. New York Heart Association (NHYA) heart failure class IV (i.e., unable to carry on any physical activity without discomfort, symptoms of heart failure at rest, increased discomfort with any physical activity is undertaken) 2. American College of Cardiology/American Heart Association congestive heart failure stage D (i.e., heart failure symptoms at rest, receiving end of life care). 3. Unstable angina or exercise induced angina 4. Persistent atrial fibrillation Pacemakers or combined pacemaker/ICDs will be excluded Presence of unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disease; or any other condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the subject or that could prevent, limit, or confound the protocol-specified assessments
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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 Cardiomyopathy Premature Ventricular Contractions VT: 1. Patient must have documented sustained monomorphic ventricular tachycardia as documented on either a 12-lead ECG or intracardiac ICD interrogation OR- 2. Monomorphic PVCs documented on a 12-lead ECG. 2. Patient must have failed or become intolerant to at least one antiarrhythmic medication (amiodarone, sotalol, or mexiletine). -AND- 3. Patient must have failed at least one invasive catheter ablation procedure, or have a contraindication to a catheter ablation procedure (e.g., LV thrombus, severe pulmonary disease), or have VT thought to arise from a protected location (e.g., epicardial VT with history of previous cardiac surgery). 4. VT Patient must have either: 1. At least 3 VT episodes (sustained VT, ICD ATP or ICD shock) over previous 6 months prior to enrollment -OR- 2. >20% PVC burden with a cardiomyopathy (LVEF<50%) 5. Patient must be deemed medically fit for stereotactic body radiation therapy by the treating physician. 6. Patient must be > 18 years old. 7. Patient must be able to understand and be willing to sign an IRB approved written informed consent document. - Patient must not have past history of radiotherapy within the projected treatment field. 2. Advanced symptomatic heart failure as defined as NYHA Class IV heart failure (inotrope dependent and/or current left-ventricular assist device (LVAD)) 3. Polymorphic VT or ventricular fibrillation (VF) as a clinical heart rhythm (as determined by 12-lead ECG and/or ICD interrogation). 4. More than 3 distinct clinical VT morphologies observed (ECG or ICD interrogation or invasive EP study) OR more than 5 distinct induced VT morphologies during ECGI testing. 5. Advanced myocardial scar substrate that would require stereotactic delivery to a target volume deemed unsafe by the treating physician. 6. Unlikely to live 12 months, in the absence of VT, as best based on clinical judgment by the treating and enrolling physicians. 7. Patient must not be pregnant and/or breastfeeding and must have a negative pregnancy test within 14 days of study entry. -
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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, Seizure Syncope Patients with generalized tonic-clonic seizures and syncopes and whose blood samples were taken within 2 hours after the event 18 years or older Observed seizure Time of the event before admission was known Diagnosis of an epileptic seizure or syncope had been entered in the final discharge report Prisoner Age < 18 years old Competing explanations for serum lactate or CK elevation e.g. shock or trauma Lack of capacity for 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): 0.0-999.0, Pacemaker Ddd Indication of a bradycardia pacemaker (DDDR, VVIR) CRTP, CRTD, ICD Very skinny patient deemed as such by implanting physician to clearly benefit from intramuscular 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): 0.0-100.0, Intimate Partner Violence Migration background was defined according to current law (MighEV §6, Sozialgesetzbuch) [45]. In detail this means that migration background is fulfilled, if (1) the person does not possesses the national citizenship, or (2) the origin of birth is outside the borders of the national country, and emigration to the national territory was after 1949, or (3) origin of birth of one of the two parents is outside the current borders of the national territory plus emigration of one of the two parents occured after 1949 If other than
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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 Atrial Fibrillation Supraventricular Tachycardia Male or female Written informed consent Patients with one or more of the following 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 Cognitive deficits that would interfere with the subject's ability to give informed consent or perform study testing
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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): 14.0-999.0, Cardiac Disease Syncope Syncope, Vasovagal Sick Sinus Syndrome Candidates must meet all of the required for in one of the two groups (summarized in Table 2). All of the patients need to have a positive P wave of > 0.5 mm in lead 2. Patients must have had ≥ 1 syncope during the 6 months preceding enrollment and ≥ 2 syncopes in their lifetime except if the last syncope was complicated by an injury or an accident, in which case further waiting for CardNM may be less desirable. Patients < 18 years must have least 3 syncopes with an interval exceeding 1 month unless 1 syncope was complicated by an injury or an accident. If a significant rate drop (> 15%) is noted during head-up tilt test (HUT), either isolated or combined with vasoplegia, and associated with syncope or severe presyncope, patients will be eligible for in group A. If the HUT is negative and a pause > 3 seconds has been documented, patients will be assigned to group B. If both conditions are present, patients will be eligible for in either group but will be preferentially assigned to group A Candidates will be excluded if ANY of the following apply (detailed in Table 3) < 14 years of age Inability to provide consent Chronotropic negative medications (excepted in patients with a previous history of atrial fibrillation) g amiodarone intake during the 2 months preceding enrollment Alternating right bundle branch block (RBBB) and left bundle branch block (LBBB), HV interval > 70 ms LBBB, bifascicular block (RBBB + left anterior hemiblock [LAHB], RBBB + left posterior hemiblock [LPHB]) PR interval permanently > 240 ms Permanent AF, PAF or electrical cardioversion during the last 6 months Valvular or subvalvular aortic stenosis, mitral stenosis
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-75.0, Coronary Heart Disease The coronary artery disease was defined by one of the following criteria-(1) based on World Health Organization in terms of elevations of cardiac enzymes, electrocardiography (ECG) and clinical symptoms (angina, chest pressure, or shortness of breath); (2) angiographic evidence of more than 50% stenosis in one or more major coronary arteries; (3) previous history of PCI (percutaneous coronary intervention) or CABG (coronary artery bypass graft). The controls were selected from the two medical centers meeting the following (1) with no family history for CAD; (2) no clinical symptoms for CAD; (3) resting ECG showed normal results. The subjects with two or more risk factors of CAD (age>45 for man and >55 for woman, hypertension, diabetes, overweight, hyperlipidemia) were subjected to treadmill stress test and selected as controls if their ECG were normal without clinical symptoms Those with history of cardiomyopathy, valvular disease, peripheral vascular disease, stroke, severe hepatic and kidney deficiency were excluded in our study
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Anesthesia Patients that meet the following will be invited to participate in this study: 1. Patients who undergo surgical procedures associated with a post operative hospital stay of at least 24 hours. 2. Patients with known or suspected obstructive sleep apnea (OSA). Known OSA will be defined as a sleep hypopnea study within the last 10 years that is consistent with OSA. Suspected OSA will be defined as a patient with a screening questionnaire (STOP-Bang) score of 5-8 (A score consistent with a high risk of OSA). The STOP-Bang questionnaire is a built in component of the anesthesia preopreative evaluation in EPIC. OR 3. Patients who will undergo surgical procedures associated with significant post operative pain and require opioid analgesics to manage pain. Sample procedures major extremity surgery, spine surgery, abdominal surgery, and chest surgery that require a post operative in patient hospital stay. Nurses who meet the following will be invited to participate in this study: PACU nurses who are in charge of caring for consented patients Patients who are discharged home on the day of surgery. 2. Vulnerable populations including pregnant women, prisoners, and people requiring legally authorized representative for consent 3. There are no for PACU Nurses
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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): 30.0-999.0, Syncope Emergency Department patient Age 30 years or above Chief complaint of syncope Capacity to make medical decisions Speak and read English Working phone number and fixed address Altered Mental Status Cognitive Impairment Serious acute diagnosis: (e.g. clinically significant cardiac dysrhythmia, structural heart disease, gastrointestinal hemorrhage, myocardial infarction, pulmonary embolism, pneumonia, arterial dissection, serious infection, ectopic pregnancy, subarachnoid hemorrhage, or stroke.) Hemodynamic instability Inability to read or speak English Major communication barrier Lack of phone number or fixed address Too high risk as per physician judgment
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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 Ventricular Fibrillation Sudden Cardiac Death Coronary Angiography Electrophysiologic Testing (EP) Catheter Ablation Percutaneous Coronary Intervention (PCI) Internal Cardioverter Defibrillator (ICD) Hospitalization due to ventricular tachycardia ventricular fibrillation sudden cardiac death not diagnosed with one or more of the above
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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, Tachycardia, Ventricular Patient has recurrent, symptomatic, monomorphic VT 2. Patient has drug refractory or drug intolerant VT following use of at least one Class III antiarrhythmic as demonstrated by a recurrent arrhythmia and is not a suitable candidate per the investigator's expert opinion for ongoing or alternative drug therapy 3. A prior failed ablation as evidenced by ICD device therapy within the prior 6 months. 4. Patient has minimum 3 month ICD interrogation history available for evaluation 5. Patient has LVEF > 20%, confirmed by echo or comparable technique during baseline evaluation 6. Patient is at least 18 years old 7. Patient has signed the informed consent, and is willing and able to participate in all study procedures and follow up requirements Patients with idiopathic VT 2. Patients with VT with ECG or MRI/CT findings suggestive of right ventricular free wall origin findings. 3. Patients with VTs of septal origin may be excluded as such ablations require special care to minimize the risk of heart block, particularly within 2 cm of the AV node/proximal conduction system. Patients requiring ablation at such locations should only be included when the arrhythmia itself is life-threatening or otherwise sufficiently severe to justify the risk. 4. Patient with myocardial infarction (MI) or unstable angina within previous 60 days 5. Patient with cardiac surgery or percutaneous coronary intervention (PCI) within previous 60 days 6. Patient with class IV (NYHA) heart failure 7. Patient with mechanical mitral valve, severe aortic stenosis or flail mitral leaflet 8. Patient with left ventricular assist device planned or required for the procedure 9. Patients with co-morbidities such that they have less than 1 year life expectancy 10. Patient with significant intracardiac and/or laminated thrombus evident by transesophogeal echo (TEE) or transthoracic echo (TTE) (with contrast) within 2 days of the ablation procedure 11. Patient with thrombocytopenia or other coagulopathy 12. Women who are or may potentially be pregnant. (must be post-menopausal or have a negative pregnancy test) 13. Patient with other acute illness or active systemic infection (unrelated to VT or its origin) 14. Significant congenital anomaly heart disease or anomaly 15. Allergy or contraindications to the medications/agents used during a standard ablation/EP intervention. 16. Patient concurrently enrolled in any other investigational drug or device study that the investigator deems would interfere with study results
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 21.0-90.0, Atrial Fibrillation Abnormal Heart Rhythms aged 21-80 yrs who underwent electrophysiology study for ablation of Atrial Fibrillation Poor data quality of recordings of AF
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 21.0-99.0, Myocardial Infarction Acute ischemic symptoms compatible with diagnosis of MI, such as chest pain or anginal equivalent symptoms at rest or new onset exertional anginal equivalent symptoms Objective evidence of MI (either or both of the following) Elevation of troponin to above the laboratory upper limit of normal (ULN) ST segment elevation of ≥1mm on 2 contiguous ECG leads Willing to provide informed consent and comply with all aspects of the protocol Administration of aspirin at least 1 hour before cardiac catheterization Administration of thienopyridine (e.g., clopidogrel, ticagrelor) at least 1 hour before cardiac catheterization Women and men with ≥50% of any major epicardial vessel on invasive angiography may participate Recent use of vasospastic agents, such as cocaine, triptans, or ergot alkaloids (≤1 month) Alternate explanation for troponin elevation, such as hypertensive urgency, acute exacerbation of heart failure, chronic elevation due to kidney disease, pulmonary embolism, cardiac trauma Pregnancy Thrombolytic therapy for STEMI (qualifying event) Use of any of the following medications Platelet antagonists (except aspirin and thienopyridines) within 7 days NSAIDs (e.g., ibuprofen, naproxen) within 3 days Thrombocytopenia (platelet count <100,000) Thrombocytosis (platelet count >500,000) Anemia (hemoglobin <9 mg/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): 18.0-90.0, Ventricular Arrythmia Ventricular Premature Complexes Ventricular Tachycardia Ventricular Tachycardia Ventricular Premature Complexes Organic ventricular tachycardia or ventricular premature complexes Drug-induced ventricular tachycardia or ventricular premature complexes
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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, Sarcoidosis Symptoms Palpitations/presyncope/syncope Heart failure symptoms Signs Abnormal ECG or Holter RBBB, LBBB, LAFB Abnormal Q waves in ≥2 leads t degree AVB > 240 msec, 2nd/3rd deg. AVB Frequent PVCs VT (sustained/non-sustained) LVEF < 50% Low likelihood of CS/Other explanation for symptoms Inability to consent 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): 18.0-70.0, Cardiac Arrest Heart Arrest Sudden Cardiac Arrest Cardiopulmonary Arrest Death, Sudden, Cardiac Cardiopulmonary Resuscitation CPR Extracorporeal Cardiopulmonary Resuscitation Extracorporeal Membrane Oxygenation OHCA of presumed non-traumatic etiology requiring CPR Predicted arrival time at ECPR-capable hospital within timeframe specified Witnessed arrest or initial shockable rhythm (VT or VF) Persistent cardiac arrest after initial cardiac rhythm analysis and shock (if shock is indicated) Sustained return of spontaneous circulation (ROSC) Advanced directive indicating do not attempt resuscitation (DNAR) or do not intubate (DNI) Preexisting evidence of opting out of study Prisoner Pregnant (obvious or known) ECPR capable ED is not at the destination hospital as determined by EMS Legally authorized representative (LAR) or family member aware of study and refuses study participation at the scene
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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, Sudden Cardiac Death Unexplained cardiac arrest requiring cardioversion or defibrillation 2. Willing and able to sign informed consent Coronary artery disease (stenosis > 50%) and clinical findings consistent with an ischemic arrest 2. Reduced left ventricular function (left ventricular ejection fraction < 50%) on echocardiogram or cardiac MRI. 3. Persistent resting QTc > 460 msec for males and 480 msec for females 4. Resting QTc < 350 msec 5. Type I Brugada ECG with >/= 2 mm ST elevation in V1 and/or V2 (Spontaneous or Drug-Induced) 6. Polymorphic or bidirectional ventricular tachycardia observed with exertion on exercise treadmill testing 7. Clinical, electrocardiographic, and/or imaging findings consistent with a diagnosis of arrhythmogenic right ventricular cardiomyopathy 8. Myocarditis 9. Reversible cause of cardiac arrest such as marked hypokalemia (<2.8 mmol/l) or drug overdose sufficient in severity without other cause to explain the cardiac arrest. 10. Arrhythmic mitral valve prolapse syndrome 11. Documented ventricular fibrillation initiated by a short-coupled premature ventricular contraction
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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, ECG Brugada Pattern Symptomatic BrS patients with typical BrS-related symptoms (cardiac arrest or syncope) or without typical BrS-related symptoms (dizziness, palpitations, presyncope, dyspnea) ICD implantation, spontaneous or ajmaline-induced type 1 Br pattern Age < 18 years, prior epicardial ablation, pregnancy, co-morbidities
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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, Cardiac Arrest Due to Underlying Cardiac Condition Ventricular Fibrillation Cardiopulmonary Arrest With Successful Resuscitation Adult presumed or known to be 18-75 years old Resuscitated from OOHCA Initial cardiac arrest rhythm of pulseless VT/VF (including patients treated with an AED) No ST-segment elevation MI (No STEMI) (or STEMI-equivalent syndrome) on ED 12-lead ECG (as interpreted by a physician) Initial non-shockable out-of-hospital cardiac arrest rhythm (pulseless electrical activity or asystole) Valid do not resuscitate orders (DNR) Blunt, penetrating, or burn-related injury, drowning, electrocution or known overdose Known prisoners Known pregnancy ST-segment elevation on ED 12-lead ECG (as interpreted by a physician) Absolute contraindications to emergent coronary angiography including known anaphylactic reaction to angiographic contrast media active gastrointestinal or internal bleeding, or severe concomitant illness that drastically shortens life expectancy or increases risk of the procedure
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Open Reduction and Internal Fixation of Extremity Fractures Previous fracture fixation with an implant (intramedullary nail, plate, screws), or joint revisions, or periprosthetic fracture, or admitted from orthopaedic trauma clinic due to infection, or inpatient with a known infection English speaking Patients with planned follow-up at another medical center Patient lives outside of the hospital catchment area
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-80.0, Ventricular Tachycardia Ischemic Cardiomyopathy Reduced LVEF left ventricular ejection fraction (TTE or MRI) ≤40% diagnosed ischemic heart disease nonsustained monomorphic VT with more than 5 beats in the record of the implantable cardioverter-defibrillator or in any means of electrocardiogram (ECG) including ECG monitor and holter monitoring ICD implantation with primary preventive indication ICD implantation within 2 months previously documented sustained VT/VF (over 30 seconds) or adequate ICD shock no written informed consent
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-75.0, Atherosclerosis Cardiovascular Diseases Age ≥18 and ≤75 years With or without significant coronary artery disease on CCTA Written informed consent Chronic infections Diabetes mellitus Medical history of any disease associated with immune deficiency Clinically significant infections within 3 months prior to study entry Recent hospital admission or surgery with general anaesthesia Known chronic kidney or liver disease Previous vaccination within 3 months prior to study entry Inability to personally provide written informed consent Inability to undergo PET-CT scanning Chronic use of anti-inflammatory drugs such as NSAIDs
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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): 65.0-85.0, Hemodynamic Instability Adult patients, aged more than 65 years scheduled for elective total knee arthroplasty under regional anesthesia contraindication to regional anesthesia or the patients who refused to give consent patients with anemia (hemoglobin < 13 g/dl for male and hemoglobin < 12 g/dl for female) cardiac arrhythmias NYHA score > 2 ASA > 2 Cardiac ejection fraction < 50 % valvulopathy pulmonary artery hypertension and relaxation abnormality
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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, Atrial Arrhythmia Atrial Tachycardia Congenital Heart Disease Pacemaker Re-Entrant Tachycardia must have structural CHD, an atrial arrhythmia and an ATD implanted. ATP must be turned on Other arrhythmias substrates such as Long QT (LQT), hypertrophic Cardiomyopathy (HCM), Catecholaminergic polymorphic ventricular tachycardia (CPVT), Arrhythmogenic Right Ventricular Cardiomyopathy.(ARVC), Brugada & patients who undergo transplant, surgical maze, or ablation within 5 years of ATD implantation
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0
|
65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Heart Failure Subject has CardioMEMS HF PA Sensor and a commercially-approved HeartMate LVAD (Group A) OR Subject has commercially-approved HeartMate LVAD, is experiencing NYHA class III symptoms, and has had a previous HF hospitalization and meets FDA indications for CardioMEMS. The CardioMEMS sensor must be implanted within 72 hours of consent (Group B) 2. Signed an informed consent form and agreed to provide access to patient and device data (including CardioMEMS Merlin.net data) 3. No connectivity or transmission problems with CardioMEMS 4. On HeartMate LVAD support for at least 3 months 5. Age ≥ 18 years Current participation in an investigation that is likely to confound study results or affect study outcome 2. Current participation in the IDE Clinical trial and has not completed the two year follow-up for that trial 3. Inability to perform 6MHW test due to conditions other than heart failure (e.g. severe arthritis, orthopedic issues, amputation etc.)
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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): 16.0-99.0, Arrhythmia 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 Refusal to sign consent form 2. Already taking PPI or H2 blocker 3. Frequency of symptoms less than 2 times per week
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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, Heart Failure Branch Block, Bundle Heart Failure, NYHA II, III, outpatient IV LVEF ≤35% measured by echocardiography Optimal medical treatment for heart failure Bundle Branch Block Indication for primary CRT-D or CRT-P implantation or upgrade from RV pacing (pacemaker or ICD) to CRT-D or CRT-P Ischemic heart disease (IHD) or non-IHD Sinus rhythm or atrial fibrillation Life expectancy >2 years Signed informed consent NYHA class I Acute mycardial infarction (AMI) within the latest 3 months Coronary artery bypass graft (CABG) within the latest 3 months Life expectancy <2 years Participation in another clinical trial of experimental treatment Contraindication for establishing implantable device treatment Previously implanted CRT system Does not wish 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): 18.0-55.0, Heart Failure For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Healthy Subjects (Part A and B) Healthy subjects, as determined by no clinically significant deviations in medical history, physical examination, ECGs, vital signs, and clinical laboratory determinations Subjects must be willing and able to complete all study-specific procedures and visits Additional criterion for Japanese subjects in Groups BJ1 to BJ3: Subjects must be first generation Japanese (born in Japan and not living outside of Japan for > 10 years, and both parents are ethnically Japanese) Heart Failure Patients (Part C) Left ventricular EF <45% and >25%, as assessed by cardiac MRI within 3 months of first dose of study drug; or left ventricular EF <40% and >25% as assessed by echocardiogram at Screening or within 3 months of first dose of study drug; left ventricular EF Heart failure is considered to be stable at the discretion of the Investigator (i.e., no acute cardiovascular [CV] events or hospitalization (including emergency room visits) for CV causes within 3 months of first dose of study drug Regular sinus rhythm at Screening and no history of atrial fibrillation in the past 12 months Healthy Subjects (Part A and B) Major surgery within 4 weeks of (first) study treatment administration Inability to be venipunctured and/or tolerate venous access Subjects who have smoked or used smoking cessation or nicotine containing products (including, but not limited, to e-cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum, varenicline, bupropion) within 6 months of the first dose of study drug Heart Failure Patients (Part C) Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption Major surgery within 4 weeks of (first) study treatment administration Inability to be venipunctured and/or tolerate venous access Other protocol defined inclusion/ could apply
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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, Fluid Responsiveness Echocardiography All Critical ill-patients with Acute Physiologic Assessment and Chronic Health Evaluation II score (APACHE II score)≥ 25 Bad echocardiographic window 2. II score < 25
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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 Cardiomyopathy Patients affected by cardiomyopathies with and without documented family history of BrS Presence of symptoms attributable to VA and/or presenting documented arrhythmic episodes Patients with an ICD already implanted Patients referred to the centre for an electrophysiological study and indication for a potential concomitant radio-frequency catheter ablation (RFA) of ventricular tachycardia (VT) or ventricular fibrillation (VF) Age ≥ 18 Willingness to attend follow-up examinations Written informed consent for the participation in the trial Pregnancy or breast-feeding 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): 45.0-85.0, Coronary Artery Disease Ischemia Clinical indication for invasive coronary angiography or CT angiography Documented coronary artery disease defined as presence of one or more of the following CAD documented by invasive coronary angiography or CT angiography History of typical stable angina and receiving guideline-driven therapy for coronary artery disease for ≥ 1 month prior to consent History of hospitalization for unstable angina with no active acute coronary syndrome within 48 hours prior to scan Refractory angina defined as marked limitation of ordinary physical activity or inability to perform ordinary physical activity without discomfort, with an objective evidence of myocardial ischemia and persistence of symptoms despite optimal medical therapy, life style modification treatments, and revascularization therapies Able to understand and willing to sign the Informed Consent Form Known allergy to iodinated contrast media History of contrast-induced nephropathy History of multiple myeloma or previous organ transplantation Elevated serum creatinine (> 1.5mg/dl) OR calculated creatinine clearance of < 60 ml/min (using the Cockcroft-Gault formula) Atrial fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular block (second or third degree heart block) Evidence of severe symptomatic heart failure (NYHA Class III or IV); Known or suspected moderate or severe aortic stenosis Previous coronary artery bypass or other cardiac surgery Coronary artery intervention (PCI) within the last 6 months Known or suspected intolerance or contraindication to beta-blockers including Known allergy to beta-blockers
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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, Right Ventricular Failure Pulmonary Embolism Participants will be patients who present to the emergency department or are inpatients in the hospital, who are found to have a diagnosis of acute pulmonary embolism (confirmed by computed tomography pulmonary angiography), and who have been referred to Interventional Radiology for evaluation for CDT. Patients appropriate for recruitment into this study will have large PEs involving lobar branches or more central segments of the pulmonary arteries will be limited to prisoners, pregnant women, patients for whom English or Spanish is not a first language, severe claustrophobia, and other routine contraindications for MRI. Patients with massive PE (resulting in hemodynamic instability) will not be appropriate participants for this study
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0
|
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): 3.0-7.0, Follicular Tonsillitis (Chronic) Pediatric patients aged 3 to 7 years with ASA 1-II scheduled for tonsillectomy (or adenoidal tonsillectomy) History of developmental disorder, cognitive impairment, cerebral palsy History of seizures(not simple febrile convulsions) Upper respiratory infections Structural airway disease predicting difficult airway History of an adverse reaction, including allergic reactions to fentanyl
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0
|
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, Reversal of Neuromuscular Blockade Has a body mass index (BMI) < 40 kg/m2 Is categorized as ASA Physical Status Class 3 or 4, as determined by the Investigator Has a planned surgical procedure that requires NMB with either rocuronium or vecuronium Has a planned surgical procedure (e.g., gastrointestinal, urologic, or laparoscopic) that in the opinion of the investigator does not preclude maintenance of moderate or deep depth of NMB throughout the case If female who is not of reproductive potential, is one of the following: (1) postmenopausal; (2) has had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to screening; (3) has a congenital or acquired condition that prevents childbearing; or (4) is undergoing surgical sterilization (e.g., hysterectomy or tubal ligation) as the planned surgical procedure associated with participation in this study If female who is sexually active and of child-bearing potential, agrees to use a medically accepted method of contraception through seven days after receiving protocol-specified medication. Abstinence (relative to heterosexual activity) can be used as the sole method of contraception if it is consistently employed as the subject's preferred and usual lifestyle and if considered acceptable by local regulatory agencies and Ethics Review Committees/Institutional Review Boards Is able to provide (or the participant's legally authorized representative, in accordance with local requirements), written informed consent for the trial. The participant or legally authorized representative may also provide consent for Future Biomedical Research Has a pacemaker or automatic implantable cardioverter-defibrillator that precludes the assessment of bradycardia or arrhythmias Has a medical condition or surgical procedure that precludes reversal of neuromuscular block at the end of surgery Has a neuromuscular disorder(s) that may affect neuromuscular block and/or trial assessments Is dialysis-dependent or has severe renal insufficiency, defined as estimated creatinine clearance of <30 mL/min Has or is suspected of having a personal history or family history (parents, grandparents, or siblings) of malignant hyperthermia Has or is suspected of having an allergy (e.g., hypersensitivity and/or anaphylactic reaction) to study treatments or its/their excipients, to opioids/opiates, muscle relaxants or their excipients, or other medication(s) used during general anesthesia Has received or is planned to receive toremifene within 24 hours before or within 24 hours after study medication administration Has any condition that would contraindicate the administration of study medication Is pregnant, is attempting to become pregnant, or is lactating Is currently participating in or has participated in an interventional clinical trial (including any other current or ongoing trial with a sugammadex treatment arm) with an investigational compound or device within 30 days of signing the informed consent form of this current trial
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0
|
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, Refractory Ventricular Tachycardia Documented sustained ventricular arrhythmias refractory to or not a suitable candidate for catheter based RFA ablative therapy Documented sustained ventricular arrhythmias refractory to or not a suitable candidate for cardiac sympathetic denervation therapy Documented ventricular arrhythmias refractory to or not a suitable candidate for cardiac transplantation Documented sustained ventricular arrhythmias refractory to or not a suitable candidate for additional medical management ICD in place with documented episodes recurrent VT despite best clinical management previous refusal of ICD with recurrent sustained ventricular arrhythmias If ischemic cardiomyopathy, myocardial infarction occurred more than one month prior to enrollment No history of prior radiotherapy to the chest Prescribed dose must be deliverable using SABR technique Age ≥ 18 years Karnofsky Performance Status (KPS) > 70
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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, Syncope Bradycardia Tachycardia Sudden Cardiac Death Ventricular Tachycardia Ventricular Fibrillation pre-operative clinical history taking 2. pre-operative functional investigations (cardiac echo, electrocardiograms) 3. pre-operative laboratory data evaluation (kidney function, liver function, biomarkers, thyroid hormone, CBC) no written informed consent
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-60.0, Epilepsy Hard-to-treat focal epilepsy 2. Aged 18 to 60 years 3. If female not pregnant Known clinical relevant structural cardiac disease 2. Implanted pacemaker, including cardiac resynchronisation device, or defibrillator 3. Use of beta blockers or other antiarrhythmic medication 4. Diagnosis of psychogenic non-epileptic 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): 19.0-80.0, Permanent Pacemaker Implantation Patients who developed atrial fibrillation/flutter/tachycardia after pacemaker implantation among AF-pacemaker study (ClinicalTrials.gov Identifier: NCT03303872) Age: 18-80 years Patients eligible for the indications for permanent pacemaker implantation in accordance with 2016 revised Korean indication guideline on cardiac pacemaker implantation Estimated percentage of atrial pacing >40% under sinus rhythm (LR≥60bpm, close hysteresis and rest rate) Estimated percentage of ventricular pacing >40% under sinus rhythm (LR≥40bpm, DDD pacing, close hysteresis and rest rate) Patients who are willing to sign the informed consent Patients who are willing to receive the implantation and post-operative follow-up Persistent or permanent AF Severe hepatic and renal insufficiency (AST or ALT ≥ three times of normal upper limit; SCr > 3.5 mg/dl or Ccr < 30ml/min) Thyroid gland dysfunction Pregnancy Malignant tumor Severe organic heart disease (such as moderate to severe mitral regurgitation, severe valvular regurgitation and stenosis, dilated cardiomyopathy, hypertrophic cardiomyopathy, severe heart valve disease) Life expectancy < 12 months Patients unable or unwilling to cooperate in the study procedures
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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 undergoing ventricular tachycardia patients with ischemic cardiomyopathy according to European Society of Cardiology Guidelines patients with implanted cardiac defibrillator Contra-indication to stress test permanent atrial fibrillation permanent ventricular pacing left bundle 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, Corticosteroids Adverse Reaction Starting high-dose intravenous corticotherapy None
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Syncope Age >= 18 years visiting the Emergency Department history of syncope in the past 24 hours: loss of consciousness, rapid onset, short duration (<1 min), transient, with spontaneous and rapid recovery without post event confusion With or without prodromes Without any other obvious cause Informed written consent Affiliation to a social security system (AME Excepted) Other for PE suspicion : Acute onset of dyspnea Acute severe chest pain Pregnancy Concurrent anticoagulation treatment Other obvious cause of syncope : Seizure, Stroke, Traumatic brain injury , toxic intake , Atrioventricular block type 3
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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): 10.0-18.0, Congenital Heart Disease Health Related Physical Fitness Motor Skills Cardiovascular Prevention Ages 10-18 years old CHD with moderate to complex severity according to the ACC criteria Health-related physical fitness <50th percentile (healthy reference) German speaking internet availability and an internet-capable device to use the intervention app Informed consent of parent/guardian as well as of the child Severe Arrhythmias Severe Left Heart Failure Chromosomal anomalies and/or genetic syndromes Severe physical and/or sensory impairments (hearing, visual, or psychomotor) Elective cardiac intervention within the next 6 months following enrollment
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Acute Myocardial Infarction patients over 18 years patients post-acute myocardial infarctium patients with neurological disease patients with congenital heart disease
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Ventricular Tachycardia Ischemic Heart Disease Patients will be eligible for if they fulfilled by having both of: 1. Prior myocardial infarction (pathological Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non-ischemic cause)38 and 2. One of the following VT events within the last 6 months while on Amiodarone or another class III or class I antiarrhythmic drug: A: Sustained monomorphic VT documented on 12-lead ECG or rhythm strip requiring termination by pharmacologic means or DC cardioversion, B: ≥3 episodes of symptomatic VT treated with anti-tachycardia pacing (ATP), C: ≥1 appropriate ICD shocks, D: ≥3 VT episodes within 24 hours, separated by ≥ 5 minutes, E: sustained VT below detection rate of an ICD Patients will be excluded from the trial if they: 1. Are unable or unwilling to provide informed consent. 2. Have active ischemia or another reversible cause of VT (e.g. drug-induced arrhythmia), or had recent acute coronary syndrome requiring revascularization. 3. Are antiarrhythmic drug-naïve. 4. Are known to have protruding left ventricular thrombus or mechanical aortic and mitral valves. 5. Have had a prior catheter ablation procedure for VT. 6. Are in renal failure (Creatinine clearance <15 mL/min) 7. Have NYHA Functional class IV heart failure or CCS Functional class IV angina. 8. Have had recent ST elevation myocardial infarction (< 1 month). 9. Are pregnant or have a systemic illness likely to limit survival to <1 year
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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, Heart Failure Individuals undergoing routine defibrillation threshold testing of a right ventricular implantable cardioverter defibrillator lead who also have previously placed His bundle lead or who are undergoing placement of a His bundle lead Individuals with contraindications to defibrillation threshold testing
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-80.0, Ventricular Tachycardia 80 years old, both males and females Single or dual chamber ICD or BiVentricular ICD in situ Ischemic or non-ischemic cardiomyopathy Receive a single shock from their ICD for monomorphic ventricular tachycardia ICD shock for polymorphic VT/VF or inappropriate shock Previous ventricular tachycardia ablation within 1 year NYHA Class IV heart failure or current inotrope therapy Ventricular tachycardia storm Listed for heart transplant or LVAD Pregnant as determined by urine pregnancy test prior to NIPS
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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, Paroxysmal Atrial Fibrillation (PAF) Subjects with recent-onset symptomatic AF at presentation, 2. With a duration at onset of symptoms from 1 hour to 48 hours, 3. And from one of the following categories: 1. First detected episode of paroxysmal AF 2. Recurrent episode of paroxysmal AF 3. Episode post-cardiac ablation for paroxysmal AF Subjects who are prescribed a pill-in-the-pocket regimen (flecainide or propafenone) for paroxysmal AF, or are within 3 months of having undergone ablation of paroxysmal AF, or have experienced an episode of new AF but are not currently experiencing an episode of recent-onset paroxysmal AF, or are known to have paroxysmal AF (or previously diagnosed with paroxysmal AF) and have one or more previous symptomatic episodes but are not currently experiencing an episode of recent-onset paroxysmal AF may consent to pre-study screening prior to presenting with recent-onset symptomatic AF. These subjects will be eligible to receive study drug only when presenting with symptomatic paroxysmal AF of recent-onset (i.e., ≤ 48 hours), consenting to the full study, and after meeting all criteria Subject < 18 or > 85 years of age 2. Hemodynamic and/or cardiac instability, with systolic blood pressure < 100 mmHg or > 150 mmHg, and/or ventricular heart rate < 80 bpm or > 150 bpm. For subjects to meet at least 2 of the 3 measurements of vital signs during screening (45, 30, and/or 15 minutes prior to dosing) must meet criteria. 3. Current AF episode treated with Class I or Class III antiarrhythmic drugs or electrical cardioversion. Subjects whose current AF episode has been treated with flecainide are eligible if their total cumulative exposure to flecainide (including the study drug to be administered in this study) does not exceed 320 mg within a 24-hour period, per site standard of care. 4. History of acute decompensated heart failure (HF) 5. History within 6 months prior to screening of, or present HF with a left ventricular ejection fraction (LVEF) < 45%, and/or Class II or higher HF as defined by the New York Heart Association (NYHA), and/or medication history suggestive of HF, in the opinion of the Investigator. An echocardiogram with LVEF within 6 months of screening is required to demonstrate eligibility. If no echocardiogram is available, subject must undergo a diagnostic echocardiogram using a portable handheld ultrasound device (handheld echocardiogram; HHE) during screening to confirm eligibility. 6. Evidence of current ongoing myocardial ischemia, such as signs (e.g., significant [e.g., > 2 mm] ST segment elevation or depression on ECG, echocardiographic findings suggestive of acute myocardial infarction), symptoms (e.g., angina pectoris, atypical angina pectoris), and/or being medicated with anti-anginal medication. In addition, subjects with signs of prior myocardial infarction (such as pathological Q waves) who are also taking concomitant medications for angina pectoris should be evaluated for presence of ongoing ischemia. 7. History of myocardial infarction (MI) within 3 months of screening 8. Known uncorrected severe aortic or mitral stenosis 9. Hypertrophic cardiomyopathy with outflow tract obstruction 10. Current diagnosis of persistent AF 11. One or more episodes of atrial flutter within 6 months prior to screening or atrial flutter at presentation 12. History of any of the following heart abnormalities: 1. Long QT syndrome 2. Conduction disease (e.g. second or third degree heart block, bundle brach block) 3. Diagnosed with sinus node dysfunction (e.g., sick sinus syndrome) and/or one of the following: (i) history of unexplained or cardiovascular syncope, (ii) known bradycardia suggestive of sinus node dysfunction, and/or (iii) prior electrical or pharmacological cardioversion associated with prolonged sinus or ventricular pause (e.g., >3 seconds) and/or slow ventricular rhythm (e.g., <45 bpm) at time of conversion Note: Sinus node dysfunction in AF is more prevalent in subjects >75 years old. d) Brugada Syndrome e) Torsades de pointes (TdP) 13. Any of the following ECG-related features: 1. QTc interval >480 msec at screening (estimated by the Fridericia's formula) 2. QRS duration ≥ 120 ms or history of previous documented wide QRS tachycardia 3. Predominantly (i.e., >30%) paced heart rhythm 4. Ventricular tachycardia (VT, sustained or non-sustained), or excessive premature ventricular complexes (PVCs, > 20 multifocal PVCs per hour), prior to dosing as per site telemetry. Site telemetry should be equipped with an alarm system for VT and PVCs or be continuously visually observed prior to dosing 14. Severe renal impairment (eGFR < 30 mL/min/1.73 m2) or on dialysis 15. Known abnormal liver function prior to randomization/allocation (including hepatic disease or biochemical evidence of significant liver derangement known prior to randomization/allocation) 16. Uncorrected hypokalemia (defined as serum potassium <3.6 mEq/L) at screening. If serum potassium result is <3.8 mEq/L at screening, therapeutic correction (e.g., potassium supplementation) is strongly encouraged, although reassessing the serum potassium level is not required as long as a value ≥ 3.6 mEq/L is documented at screening. 17. Subjects with established pulmonary disease in need of inhalation medication. Subjects with COPD are excluded. Subjects with mild to moderate asthma that are not experiencing active symptoms at screening and whose asthma is well controlled with steroids and/or as-needed administration of a bronchodilator are eligible for the study. 18. Known hypersensitivity to flecainide acetate or any of its active metabolites 19. Concomitant therapy with systemic drugs that are strong inhibitors of CYP 2D6 (e.g. antidepressants, neuroleptics, ritonavir, some antihistamines) or CYP 2D6 inducers (e.g. phenytoin, phenobarbital, carbamazepine) 20. Treatment with Class I or Class III antiarrhythmic drugs within the last week. Subjects whose current AF episode has been treated with flecainide are eligible if their total cumulative exposure to flecainide (including the study drug to be administered in this study) does not exceed 320 mg within a 24-hour period, per site standard of care. 21. Treatment with amiodarone within the last 12 weeks 22. Subject is deemed unsustainable for the trial by the Investigator (including but not limited to: patients who are considered at high risk for stroke based on screening coagulation panel or medical history (e.g., CHA2DS2-VASc score); patients with congenital heart disease; patients with history of AF refractory to pharmacological or electrical cardioversion; patients whose AF is secondary to electrolyte imbalance, thyroid disease, or other reversible or non-cardiovascular cause; patients with episodes of syncope; patients with any serious or life threatening medical condition; patients with any acute infection). The subject may be deemed unsuitable for the trial by the Investigator if the subject is not able or willing to inhale the study drug. 23. Known drug or alcohol dependence within the past 12 months as judged by the Investigator 24. A body mass index > 40 Kg/m2 25. Legally incompetent to provide informed consent (IC) 26. Previous randomization/allocation in this study or treatment with any other investigational drug within 30 days from screening or 5 half-lives of the drug, whichever is longer 27. Female of childbearing potential 1. Who are not surgically sterile, or post-menopausal (defined as no menses for 2 years without an alternative cause), or 2. For whom a negative pregnancy test is unavailable before study entry, or 3. Who are pregnant or breast feeding at study entry 28. Previous administration of flecainide for an episode of paroxysmal AF or new AF did not result in conversion of AF to SR (i.e., subject is considered a non-responder to flecainide) 29. Cardiac surgery for any of the exclusionary conditions (e.g., valvular disease, hypertrophy, coronary artery disease [CAD], etc.) within the last 6 months prior to screening 30. Respiratory rate of > 22 breaths per minute
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 40.0-75.0, Right Coronary Artery Occlusion Patients subjected to elective PCI due to right coronary artery occlusion. Patients between 40 and 75 years old from the both genders History of chronic respiratory condition and PHTN 2. Patients with previous percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG). 3. History of valvular surgery. 4. Patients with significant rheumatic vavular heart disease. 5. Presence of persistant arrythemia 6. Patients with End stage renal disease. 7. Patients with End stage liver disease. 8. Haemodynamically unstable patients. 9. Patients with previous Myocardial infarction. 10. Patients with Ischemic Dilated Cardiomyopathy. 11. Patients with pericardial disease. 12. Patients with congenital intra-cardiac shunt
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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, Long QT Syndrome QT time in EKG more Tham 500 ms - Patient refuses to be a part of the study registry
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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, Amyloidosis to 65 years of age inclusive at the time of signing the informed consent Non-smokers only (defined as a non-smoker during the last 3 months prior to screening) Body weight > 50 kilograms and body mass index (BMI) and <=30 kilograms/meter square Male subjects and women of non-child bearing potential only will be eligible Male subjects with female partners of childbearing potential must comply with one of the following contraception requirements from the time of first dose of study medication until completion of the follow-up visit Vasectomy with documentation of azoospermia Male condom plus partner use of one of the contraceptive options: Contraceptive sub dermal implant that meets the effectiveness of a <1% rate of failure per year, as stated in the product label; Intrauterine device or intrauterine system that meets the standard operating procedure (SOP) effectiveness including a <1% rate of failure per year, as stated in the product label; Oral Contraceptive, either combined or progestogen alone; Contraceptive vaginal ring; Occlusive cap (female diaphragm or cervical/vault cap) with a vaginal spermicide (foam, gel, cream or suppository) Capable of giving signed informed Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the or outside the reference range for the population being studied may be included only if the investigator in consultation with the Medical Monitor if required agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures Aspartate aminotransferase, Alanine aminotransferase, Alkaline phosphatase and bilirubin <=1.5 ULN (Upper Limit of Normal) (isolated bilirubin >1.5 ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) History or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data Clinically significant blood pressure as determined by the investigator Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) QT interval corrected for heart rate according to Fridericia's formula (QTcF)>450 milliseconds Screening 12-lead ECG with any of the following: second/third degree atrioventricular block (AVB); significant pathological Q-waves (defined as Q-wave > 40 milliseconds or depth greater than 0.4-0.5 millivolts); ventricular pre-excitation; complete left bundle branch block (LBBB); bradycardia as defined by sinus rate <= 35 beats per minute (BPM) Any clinically relevant abnormality on the screening medical assessment laboratory examination or ECG A personal history of corrected QT interval (QTc) prolongation, symptomatic cardiac arrhythmias or cardiac arrest Sinus bradycardia <= 35 BPM or junctional arrhythmia > 60 BPM for 10 seconds or longer on run-in Holter or pre-dose inpatient telemetry
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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): 45.0-85.0, Insulin Treated Type 2 Diabetes With High Risk of Hypoglycemia Type 2 diabetes (diagnosis based on the World Health Organization criteria) Treatment with insulin therapy (continuous subcutaneous insulin Infusion or more than 1 daily injection) Resting heart beat ≥ 60bpm High risk of hypoglycemia defined as Estimated glomerular filtration rate 15-59 ml/min/1.73 m² (according to CKD-EPI formula) Or history of stable proliferative diabetic retinopathy Or body mass index ≤ 30 kg/m² Or history of severe hypoglycemia in the previous 6 months Or history of non-severe ≤70mg/dL hypoglycemia in the previous 4 weeks Type 1 diabetes mellitus or diabetes due to other cause History of atrial fibrillation Pacemaker Estimated glomerular filtration rate <15 ml/min/1.73 m² (according to CKD-EPI formula) Currently using a flash continuous Glucose Monitoring device In the investigator's opinion, acute or chronic medical condition considered as unsuitable for 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): 18.0-999.0, Chest Pain Coronary Artery Disease Acute Coronary Syndrome Ischemic Heart Disease Patients above 18 years of age with ischaemic sounding chest pain prompting visit to the emergency department (suspected ACS). 2. No-ischaemic ECG changes (i.e. no ST-segment elevation or depression 1mm in 2 or more contiguous leads, and/or T-wave inversions). 3. Episode of chest pain within last 12 hours. 4. Initial troponin in the intermediate range (5-50ng/L) STEMI. 2. Signs and symptoms of acute heart failure and/or haemodynamic instability. 3. Dynamic ischaemic ECG changes. 4. Patient not suitable to undergo CTCA 1. Inability to breath hold for 10 seconds 2. Severe renal impairment (eGFR <30 mL/min) 3. Contraindication to beta-blockers (not relevant for patients with baseline sinus rhythm at rate of <63bpm) 5. Atrial Fibrillation on ECG. 6. Patients with known significant obstructive coronary artery disease (>50% stenosis) on previous invasive or CT coronary angiogram. 7. Patients with previous PCI/CABG revascularisation. 8. Patients with a history of congenital heart disease. 9. Patients with known coronary artery anomalies. 10. Patients who lack capacity to give consent or participate in the study. 11. Previous recruitment to the present study. 12. Known pregnancy or patients who are currently breast feeding. 13. Prisoners. 14. Patients involved in current or a recent (within the last 4 months) CTIMP 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): 18.0-999.0, HIV I Infection HIV-1+ Any gender years old or older Residing in the Charlotte, North Carolina metropolitan area At least a single entry in the EHR in the last 2 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): 18.0-85.0, Sudden Cardiac Death 40 days (inclusive) following a myocardial infarct Impaired left ventricular systolic function (LVEF≤40% or at least moderately impaired) Age <18 or >85; 2. Pregnancy; 3. Nursing home resident dependent on one or more activities of daily living; 4. Significant non-cardiac co-morbidity with high likelihood of death within 1 year (this would any metastatic malignancy, or other terminal disease); 5. Significant psychiatric illnesses that may be aggravated by device implantation or that may preclude regular follow up; 6. Intravenous drug abuse (ongoing); 7. Unresolved infection associated with risk for hematogenous seeding; 8. Pre-existing implantable cardioverter-defibrillator (ICD); 9. Secondary prevention indication for an ICD (i.e. sustained ventricular arrhythmias occurring more than 48 hours after qualifying myocardial infarction (patients with ventricular arrhythmias occurring ≤48 hours of myocardial infarction, or with non-sustained ventricular tachycardia at any time, are not excluded)); 10. On the heart transplant list; 11. Recurrent unstable angina despite revascularisation (defined as ongoing chest pain or ischemic symptoms at rest or with minimal exertion despite adequate treatment with anti-anginal medications);** 12. Congestive heart failure New York Heart Association class IV, defined as shortness of breath at rest, which is refractory to medical treatment (not responding to treatment)** **NOTE: patients who meet based on (11) or (12) can be reviewed again in 2-3 days and if symptoms have resolved or treatment performed can be re-considered for 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): 18.0-70.0, Extracorporeal Cardiopulmonary Resuscitation Cardiac Arrest Witnessed cardiac arrest or signs of life during CPR (such as gasping or movement) Age>18 and < 70 years Duration of low-flow < 60 min before decision to proceed with ECPR High quality CPR (defined as end-tidal carbon dioxide (CO2et) >10 mmHg) provided for a minimum of 15 minutes without return of spontaneous circulation (ROSC) Presumed cardiac cause of cardiac arrest (such as Chest pain before collapse, ventricular tachycardia/ventricular fibrillation (VT/VF) as initial rhythm or ST-elevation on ECG) Cerebral oxymetry monitoring initiated during CPR preceding ECPR Patients with a GCS<15 before CPR Known pre-arrest cerebral performance category CPC ≥ 3 Presumed noncardiac cause Unwitnessed collapse Suspected or confirmed pregnancy ROSC within 5 minutes of Advanced cardiopulmonary life support (ACLS) performed by emergency medical service (EMS) team Conscious patient Known bleeding diathesis or suspected or confirmed acute or recent intracranial bleeding Suspected or confirmed acute stroke Known severe chronic organ dysfunction or other limitations to therapy
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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, Ventricular Tachycardia history of sustained monomorphic VT or termination of monomorphic VT by ICD (appropriate therapy) during previous 6 months prior to enrollment implantation ICD inducibility at least one of monomorphic ventricular tachycardia by ICD during EP study with programmed ventricular stimulation history of myocardial infarction (MI) left ventricular scar and decreased systolic function of the left ventricle (ejection fraction of left ventricle less than 40%) based on transthoracic ultrasound stable chronic heart failure (NYHA II-III) older than 18 years signed an IRB approved written informed consent document failed at least one invasive catheter ablation procedure or have a contraindication to a catheter ablation procedure acute myocardial infarction chronic heart failure NYHA IV channelopathy reversible cause of VT (e.g. ionic dysbalance, intoxications) pregnancy or breastfeeding history of chest radiotherapy arrhythmic substrate larger than 100 ccm
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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 Arrythmia Heart Diseases Cardiovascular Diseases Subject has sustained, monomorphic VT 2. Subject has recurrent, symptomatic VT 3. Subject has drug refractory or drug intolerant sustained VT following use of at least one Class III antiarrhythmic as demonstrated by a recurrent arrhythmia and is not a suitable candidate per the investigator's expert opinion for ongoing or alternative drug therapy 4. ECG and/or ICD evidence of a spontaneous VT recurrence within the prior 6 months that is suspected to be the same VT as initially targeted in a prior ablation 5. Subject has minimum 3-month ICD interrogation history available for evaluation 6. Subject has LVEF > 20%, confirmed by echo or comparable technique during baseline evaluation 7. Subject is at least 18 years old 8. Subject has signed the informed consent, and is willing and able to participate in all study procedures and follow up requirements Subjects with VT of idiopathic origin 2. Subjects with VT with ECG or MRI/CT findings suggestive of right ventricular free wall origin 3. Subjects with VTs of septal origin require special care to minimize the risk of heart block, particularly within 2 cm of the AV node/proximal conduction system; Subjects requiring ablation at such locations should only be included when the arrhythmia itself is life-threatening or otherwise sufficiently severe to justify the risk 4. Subject with myocardial infarction (MI) or unstable angina within previous 60 days 5. Subject with cardiac surgery or percutaneous coronary intervention (PCI) within previous 60 days 6. Subject with class IV (NYHA) heart failure 7. Subject with prosthetic cardiac valve(s), severe aortic stenosis or flail mitral valve 8. Subject with left ventricular assist device planned or required for the procedure 9. Subjects with co-morbidities such that they have less than 1-year life expectancy 10. Subject with significant intracardiac and/or laminated thrombus evident by transesophageal echo (TEE) or transthoracic echo (TTE) (with contrast) prior to ablation procedure 11. Subject with thrombocytopenia or other coagulopathy 12. Women who are or may potentially be pregnant (must be post-menopausal or have a negative pregnancy test) 13. Subject with other acute illness or active systemic infection (unrelated to VT or its origin) 14. Significant congenital heart disease or cardiac anomaly 15. Allergy or contraindications to the medications/agents used during a standard ablation/EP intervention. 16. Subject concurrently enrolled in any other investigational drug or device study
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-70.0, Out-Of-Hospital Cardiac Arrest Witnessed arrest Bystander CPR initiated before EMS arrival or EMS-witnessed arrest VF/VT as first recorded rhythm by EMS or shock delivered by AED No ROSC within 10 minutes after EMS arrival Ambulance transport with mechanical chest compression device Confirmation of ROSC End-tidal CO2 < 10 mmHg Known terminal disease (eg. cancer) Known severe comorbidity Severe chronic pulmonary disease (GOLD classification 3 or 4) Heart failure NYHA classification 3 or 4 Known history of bifemoral surgery Do Not Resuscitate (DNR) order Expected time from transport decision to start ECMO >60 minute
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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, Arrhythmias, Cardiac Cardiac Arrest Cardiac Arrythmias All ECG data compiled from 12-lead ECG, single, and multiple lead databases None
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-95.0, Total Hip Replacement Surgery Patients eligible for total hip replacement surgery in Reims University Hospital Patients agreeing to participate in the research and having signed informed consent between 18 yo and 95 yo Patients affiliated to a social security system Patients with allergy to local anesthetics Patients with neuropathy Patients with an ASA score of 4 Patients undergoing revision surgery for total hip arthroplasty Patients receiving anterior hip total hip replacement surgery Patients with a contraindication to the realization of the quadratus lumborum block, femoral block or spinal anesthesia (clinical coagulopathy, infection at the point of puncture ...) Patients refusing the proposed techniques
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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, Nicotine Dependence (MAIN STUDY): All participants must Be between the ages of 18-60. Justification: Many neural processes change with age, and these changes could introduce unwanted variability in both behavioral and MRI signals. In addition, the risk of difficult-to-detect medical abnormalities such as silent cerebral infarcts increase with age. Assessment tools: History. Government- issued forms of identification (e.g. driver s license, birth certificate) will be required when participant appears to be out of age range Be in good health. Justification: Many illnesses may alter fMRI signals as well as cognitive processes and neural functioning. Assessment tools: Medical Assessment, Medical History and Physical Examination. Medical assessments Vital Signs, EKG, oral HIV test, height/weight measurements, urinalysis and blood sample. Tests on the blood sample CBC, complete metabolic profile, TSH, ESR, STS and HIV (if needed to confirm a positive salivary test for HIV). The following individual laboratory results will independently disqualify individuals: Cholesterol greater than 250 mg/dl, Hemoglobin less than 10.5 g/dl, WBC less than 2400/ (Micro)l, LFTs less than 3 times upper normal, HCG positive, Casual serum glucose less than 200 mg/dl, Urine protein less than 1+. The MAI will retain discretion to at less extreme values, depending on the clinical presentation. (Serum glucose over 140 mg/dl will be followed up with a fasting serum glucose assessment. Those with fasting glucose below 100 mg/dl may be considered for the protocol. Others will be rejected and referred for work-up.) Liver function will be evaluated with aspartate aminotransferase (AST) and alanine transaminase (ALT). A greater than 3 times upper normal limit for AST or ALT will disqualify individuals. MAI will make the final judgment on any questionable lab results Be right-handed. Justification: Using right-handed individuals will reduce variability in BOLD MRI data. Assessment tool: Edinburgh Handedness Inventory Be able to abstain from alcohol and other substances 24hrs and caffeine for 12 hours before each of the imaging sessions. Justification: Alcohol and caffeine (among other substances) modulate neural functioning in a way that would complicate data interpretation. Assessment tools: Self-report, urine drug screen and breathalyzer For smoker group, must have a urine cotinine level of greater than 4 as measured by a semi-quantitative in vitro diagnostic (e.g., NicAlert) and have been smoking a regular combustible tobacco product consistently for at least one year. Based on the correlation between self-reported cpd/FTND and urine cotinine levels, a single criterion will be easier to manage and provide adequate characterization of dependent smokers. Urine cotinine level provides a biomarker that does not rely on self-report/memory. Quit attempts will be assessed via clinical interview and judgment. Justification: The present protocol is interested in neurobiological mechanisms that underlie nicotine dependence-induced plasticity, and is thus contingent on the presence of nicotine dependence. Assessment tools: Self-report, NicAlert of 4 or higher (or other nicotine/cotinine lab test equivalent to 200ng/ml cotinine concentration) For the smoker group, must be willing to attempt an acute abstinence period lasting approximately 48 hours on 2 separate occasions. Justification: We aim to look at the response to stimulation in both drug sated and abstinent states in smokers. Assessment tool: Self-report For the non-smoking control group, less than 20 cigarettes lifetime, no cigarette or other nicotine product in past year and no history of daily use of any other nicotine products for > 2 weeks. Justification: Minimal cigarette exposure in the control group is required to assess differences between healthy control and the smoker groups. Assessment tools: Self-report, NicAlert of less than or equal 2, CO less than 6 or MAI discretion if there is a reasonable planation for high CO exposure (MAIN STUDY) Current or personal history of cerebrovascular or neurological illnesses including, but not limited to, seizure disorders, frequent migraines or on prophylaxis, multiple sclerosis, movement disorders, history of significant head trauma, or CNS tumor. Current or personal history of any neurological disorders that would increase seizure risk from iTBS such as stroke, brain lesions, previous neurosurgery, any history of seizure or fainting episode of unknown cause, or head trauma resulting in loss of consciousness, lasting over 30 minutes or with sequela lasting longer than three months, regardless of loss of consciousness. Justification: Cerebrovascular and neurological conditions may alter blood flow, CNS function, the fMRI signal and other autonomic signals. Additionally, neurological disorders such as stroke, vascular lesions or head trauma can lower the seizure threshold and are therefore contra-indications for iTBS. Fainting episodes or syncope of unknown cause could indicate an undiagnosed condition associated with seizures. Assessment tools: TMS Safety Screen and Medical History and Physical Exam. The MAI who will also retain discretion to based on a history of neurological illness that may compromise data integrity First-degree family history of any neurological disorder with a potentially hereditary basis, including migraines, epilepsy, or multiple sclerosis. Justification: Neurological disorders can lower the seizure threshold and are therefore contra-indications for iTBS. First -degree family history of certain neurological disorder with a hereditary component increases the risk of the participant having an undiagnosed conditi n that is associated with lowered seizure threshold. Assessment tools: TMS Safety Screen and Medical History Implantable defibrillator, implanted medication pumps, cardiac pacemaker, neurostimulator, some artificial joints, metal pins, surgical clips, intracardiac lines, or acute unstable cardiac disease with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants or electrodes) or any other implant or metal object in the body that precludes MRI scanning or iTBS administrations. Justification: certain metal in the body is a contra-indication for MRI scanning and iTBS administration, which involves exposure to a relatively strong static magnetic field that can move magnetic material not securely bound and rapidly alternating magnetic fields that can generate heat and current in metal contained in the body. Assessment tools: TMS Safety Screen, MRI Safety Screen and Medical History Are not suitable to undergo an fMRI experiment due to body morphology or claustrophobia. Justification: MR scanning is one of the primary measurement tools used in the protocol. Assessment tools: MRI Safety Screen, Medical History. Prospective participants will be questioned about symptoms of claustrophobia and may be placed in the mock scanner during screening to assess for possible difficulty tolerating the confinement of the scanner and for ability to fit into the scanner. Noise-induced hearing loss or tinnitus. Justification: individuals with noise-induced hearing problems may be particularly vulnerable to the acoustic noise generated by iTBS equipment and MRI (even with the use of sound attenuation ear plugs). Assessment tools: TMS Safety Screen, MRI Safety Screen, Medical History Current use (any use in the past 4 weeks, daily use for more than a week within the past 6 months) of any substances (excluding alcohol, see 9), investigational drug or of any medications with psychotropic, anti or pro-convulsive action, or anti coagulants. This will be determined at the discretion of the MAI. Justification: the use of certain medications or drugs can lower seizure threshold during use or withdrawal and is therefore contra-indicated for iTBS. Assessment tools: Medical History, urine toxicology analysis for the presence of a broad range of prescription and non-prescription drugs. Lifetime history of schizophrenia, bipolar disorder, mania, or hypomania. Justification: The population of interest here is a healthy population with no psychiatric disorders other than tobacco use disorders. In participants with bipolar disorder, mania or hypomania, there is a small chance that iTBS can trigger (hypo)manic symptoms. Assessment tools: M.I.N.I. Potential diagnoses will be further evaluated by a counselor Current major psychiatric disorders to but not limited to, mood, anxiety, psychotic disorders, or substance-induced psychiatric disorders, or any current suicidal ideations or currently under antidepressant or antipsychotic medication treatment. The MAI will reserve the right to on the basis of psychiatric history not explicitly described in this criterion. Justification: Psychiatric disorders involve the central neural system (CNS) and, therefore, can be expected to alter the fMRI measures being used in this study. Assessment tools: M.I.N.I., Beck Depression Inventory, Beck Anxiety Inventory, Adult ADHD Self-Report Scales and clinical terview confirmation by clinician Meet current DSM-5 for moderate to severe substance use disorder, for alcohol or any drug (except nicotine for the smoker group). Past substance use disorder (SUD) is acceptable based on MAI determination. Those with past SUD of substances other than alcohol or marijuana may not have any current use (past 6 months) of the substance on which they were dependent. Individuals with past SUD of either alcohol or marijuana who report current use of the previously dependent substance may be included provided they do not currently meet withdrawal criteria. Justification: SUD of other substances (drugs or alcohol) may result in unique CNS deficits that could confound results and introduce excessive variance. Assessment tools: The Mini International Neuropsychiatric Interview (M.I.N.I) and clinical SUD assessment, Drug Use Survey, Addiction Severity Index. A positive drug test for marijuana will not be exclusionary as long as participants, based on self report, have not used in the 24hrs preceding the imaging visits. In the event of a positive drug test for marijuana, self-reports of current marijuana use will be used to differentiate intermittent/infrequent from chronic/frequent users
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 55.0-999.0, Embolic Stroke of Undetermined Source Age 55 or over Diagnosis of the index event made by a stroke specialist of an acute ischemic stroke or TIA (WHO definition) of undetermined etiology occurring within the previous 6 months (180 days). The event must be either: 1. An embolic arterial ischemic stroke confirmed by neuroimaging; or, 2. A clinical transient ischemic attack, defined as involving a focal unilateral motor deficit, speech/language deficit, or hemianopia, with symptom duration <24 hours (NOTE: amaurosis fugax/transient monocular blindness, pure sensory spells, isolated vertigo spells, etc. do not qualify for enrolment given the potential for misdiagnosis of such events) No previous ECG or Holter monitor showing atrial fibrillation (AF) or atrial flutter Informed consent from patient or legally authorized representative if patient is not competent due to stroke-related cognitive impairment, aphasia or anosognosia Patient has undergone, as per standard of care, routine CT head, vascular imaging (CT angiogram or, if GFR <30 mL/min, carotid dopplers) and echocardiography is planned within 60 days of the index event. (NOTE: if echocardiogram has already been performed within one year prior to study enrolment, it may serve as the baseline echocardiogram for study purposes) Patient is expected to survive at least 6 months Unable to participate in follow up in Vancouver Atrial fibrillation/flutter by history or on holter, ECG or telemetry Retinal stroke/TIA Most responsible etiological diagnosis for the qualifying stroke/TIA event already determined, i.e. probable small-vessel (lacunar) disease, probable large-vessel disease, cervicocephalic artery dissection, venous sinus thrombosis, hypercoagulable states, or other known cause Major-risk cardioembolic source on echocardiography (intracardiac thrombus, endocarditis, mechanical heart valve, rheumatic mitral valve disease OR Positive blood cultures at the time of the index event (i.e. more than 2 bottles at two sites or collected at different times positive for pathogen) Planned carotid endarterectomy within the next 90 days Concurrent indication for cardiac monitoring, pacemaker or implanted cardiac defibrillator Known skin reactions to synthetic polymers, hydrogel or skin breakdown at the site for extended monitor application
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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, Monomorphic Ventricular Tachycardia Ischemic cardiomyopathy, with ischemic myocardial scar Sustained monomorphic ventricular tachycardia Age > 18 years Prior ICD implantation VT storm NYHA functional class IV Additional indication for antiarrhythmic drug therapy Contraindication for both study drugs (amiodarone and sotalol) Uncontrolled myocardial ischemia LV thrombus Non-ischemic VT substrate Contraindications for anticoagulation Prior substrate ablation in the previous 6 months Cr > 2.5 mg/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): 0.0-999.0, Cardiovascular Shock Patients presenting with shock or other signs of circulatory failure (tachycardia, oliguria) Need for the physician to test preload responsiveness Patients already equipped by a central venous catheter for the measurement of CVP patients<18 years old pregnancy instaility justifying rapid increase in cathecolamines
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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): 25.0-60.0, Healthy - : 1. Healthy male and female volunteers ages 25-60 2. 2 minute HRV measurement with SDNN<35 ms (below 35 ms) 3. Participants able and willing to comply with the study protocol 4. Participants able and willing to sign a written informed consent 1. Participant with a known cardiovascular disease 2. Participants with COPD 3. Participants with any known history of epilepsy 4. Participants with detected arrhythmia on test day 5. Participants with implanted electrical and/or neurostimulation device (such as cardiac pace maker/defibrillator/VNS stimulator/SNS stimulator/occipital nerve stimulator/deep brain stimulator etc.) 6. Heavy smokers (more than 1 package of cigarets a day) 7. Participants with a plan to change medications 8. History of vasovagal syncope 9. Pregnancy or bleeding 10. Participants enrolled 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): 18.0-85.0, Heart Failure Ischemic or non-ischemic cardiomyopathy and documented heart failure for at least 6 months. 2. ACC/AHA Stage C, NYHA Class III or ambulatory Class IV HF documented at Baseline Visit. 3. Receiving maximally tolerated medical therapy for heart failure as indicated per ACC/AHA or ESC Heart Failure Guidelines (guideline-directed medical therapy or GDMT), such as diuretic, angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), beta-blocker (BB), and mineralocorticoid receptor blocker (MRB) for at least 3 months prior to the Baseline visit. 4. Receiving rhythm management device therapy as recommended by the ACC/AHA or ESC Guidelines. Specifically: cardiac resynchronization therapy (CRT) should be implanted for at least 90 days prior to enrollment; an implanted cardioverter-defibrillator (ICD) or a pacemaker should be implanted at least 30 days prior to enrollment. If subject is clinically contraindicated for these therapies this criterion may be waived. 5. Have a minimum of one (1) prior hospital admission within the last 12-months for acute worsening of HF associated with signs/symptoms of congestion of at least one (1) calendar date change duration requiring treatment with an intravenous diuretic. If CRT device previously implanted, the heart failure hospitalization must be ≥ 30 days after CRT implantation. Alternatively, if patients have not had a HF hospitalization within the prior 12-months, they must have a corrected* elevated Brain Natriuretic Peptide (BNP) level of at least 300pg/ml or an N-terminal pro-BNP (NT-proBNP) level of at least 1,500pg/ml, according to local measurement, within 30-days of the Baseline Visit. *Thresholds for NT-proBNP will be corrected for body mass index (BMI) using a 4% reduction per BMI unit over 20 kg/m2, If patient is on ARNI, NT-proBNP should be used exclusively. 6. Provide informed consent for study participation and be willing and able to comply with the required tests, treatment instructions and follow-up visits. - Age <18 or >85 years old. 2. Patients who are NYHA class IV not ambulatory and ACC stage D. 3. Patients with evidence/history of an intra-cardiac thrombus or history of stroke, transient ischemic attack, systemic or pulmonary thromboembolism, deep vein thrombosis (DVT), within the last 6 months. 4. Patients with a resting systolic blood pressure <90 or >180 mmHg and/ or Severe pulmonary hypertension with a pulmonary artery systolic pressure of ≥70 mm/Hg on screening baseline echocardiogram. 5. Left ventricular end-diastolic diameter (LVEDD) > 8cm. 6. Have an atrial septal defect or patent foramen ovale with more than trace shunting on color Doppler or intravenous bubble study or surgical or interventional correction of congenital heart disease involving atrial septum including placement of a PFO or ASD closure device and have a hypermobile septum or a septal aneurysm 7. Patients with untreated severe valve lesions, which are indicated for surgical or percutaneous intervention, severe regurgitant (grade 4+) valve lesions, active valvular vegetations, atrial myxoma, hypertrophic cardiomyopathy with significant resting or provoked subaortic gradient, acute myocarditis, tamponade, or large pericardial effusion, constrictive pericarditis, infiltrative cardiomyopathy (including cardiac sarcoidosis, amyloidosis, and hemochromatosis), or congenital heart disease, as cause of HF. 8. Uncontrolled tachyarrhythmia or bradycardia (heart rate <45). 9. Intractable HF with resting symptoms despite maximal medical therapy (ACC/AHA HF Stage D), including patients receiving continuous or intermittent outpatient IV vasoactive medications (e.g., IV inotropes, IV vasodilators), patients treated with a ventricular assist device (VAD). 10. Intolerant to diuretics, ACEI and ARB and beta-blocker medical therapy for patients classified as HFrEF (EF ≤40%). 11. The presence of an acute coronary syndrome (ACS), percutaneous coronary intervention (PCI), rhythm management system revision, lead extraction, or cardiac or other major surgery within the preceding 90 days. 12. Patients not eligible for emergency open-heart, thoracic or vascular surgery. 13. Women of childbearing age 14. Patients with a life expectancy that is shorter than 12 months, or those who have received a cardiac transplant or are listed for cardiac transplantation and likely to be transplanted within 12 months. 15. Have coagulopathy or uninterruptible anticoagulation therapy or contraindication for all of the forms of antiplatelet/anticoagulant treatments anticipated in the protocol 16. Have an estimated glomerular filtration rate <25 ml/min/1.73 m2 by the MDRD method or on dialysis. 17. Hepatic impairment with at least one liver Function Test (transaminases, total bilirubin, or alkaline phosphatase) ≥ 3 times upper limit of normal. 18. Gastrointestinal bleeding in the last 6 months 19. Have severe chronic pulmonary disease requiring continuous home oxygen, chronic oral steroid therapy, hospitalization for exacerbation during prior 6 months, or has severe obstructive physiology on PFTs (FEV1/FVC <0.70 and FEV1 < 50% normal). 20. Patients who have an active infection requiring systemic antibiotics or an elevated white blood count (above the local laboratory reference ranges) 21. Have a history of active drug addiction, active alcohol abuse, or psychiatric hospital admission for psychosis within the prior 2 years. 22. Are currently participating in a clinical investigation that includes an active treatment arm. 23. Subject otherwise not appropriate for study as determined by the investigator. The reasons must be documented. 24. Patients contraindicated for trans-septal puncture, TEE or ICE. Intra Procedural (Intra Procedural will be determined immediately after intracardiac echocardiography or transesophageal echocardiography determination of left atrial anatomy and just before trans-septal puncture) 25. Anatomical anomaly on TEE or ICE that precludes implantation of the V-LAPIM across the interatrial septum (Fossa Ovalis) including: Septal thickness at fossa > 5 mm, FO Dimension <16mm, ASD or PFO with more than a trace amount of shunting, Intra cardiac thrombus felt to be acute and not present on prior exams and Abnormal septum, e.g. a hypermobile septum or a septal aneurysm. 26. Inadequate vascular access for implantation of V-LAPIM or are unable to tolerate an RHC. 27. Hemodynamic at time of Index Procedure including: Severe pulmonary hypertension defined as PASP>70 mmHg or PVR >4.0 Woods Units (mmHg L-1 min-1); Resting systolic Blood Pressure <90 or >180 mmHg, not corrected with IV fluid administration or vasodilators, respectively
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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 Catheter Ablation Follow-Up Studies Electrodes patients with recurrent, sustained ventricular tachycardia patients implanted with implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy cardioverter defibrillator (CRT-D) patients planned for 3D mapping and radiofrequency ablation of ventricular tachycardia myocardial substrate patients who are able to understand and sign informed consent Patients with combined mechanical aortic and mitral valve prostheses Patients with RF ablation of VT done in the last 12 months Patients with known damaged ICD/CRT-D electrode or battery Patients undergoing VT ablation who have not been implanted with ICD or CRT-D Patients not willing or able to undergo clinical follow-up of ICD/CRT-D device Patients with life expectancy < 1 year Not able to understand or willing to sign informed consent Age < 18 years
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-75.0, Pulmonary Arterial Hypertension Non smoker or tobacco stopped for minimum 2 years ans maximum 10 year-pack. - Idiopathic, heritable, related to drug or toxics, associated with controlled pulmonary hypertension. Diagnosis and treatment of pulmonary hypertension for more than 4 months Optimal control of pulmonary hypertension (no right heart failure symptom and NTproBNP < 300ng/L or Brain Natriuretic Peptide(BNP) < 50 ng/L and optimal hemodynamic results measured by a right heart catheterization in the last year: right atrial pressure < 8 mmHg, cardiac index > 2,5 L/min/m2, veinous saturation in oxygen > 65%) Informed and written consent Non-affiliation to a social security Existence of another form of pulmonary hypertension Existence of vocal cord dysfunction Pregnancy Obesity> stage 2 (BMI 35 kg / m2) Age ≥ 75 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): 50.0-70.0, Diabetes Mellitus, Type 2 diagnosis of type 2 diabetes for at least 12 months glycated hemoglobin bellow 10 % not having started insulin therapy in the previous six months not having started therapy with sulfonylureas in the previous six months major complications of diabetes screened and controlled (diabetic retinopathy, diabetic nephropathy and diabetic foot) no symptoms of coronary artery disease no cardiovascular, respiratory and musculoskeletal contraindications to exercise not under cancer treatment (radiotherapy or intravenous chemotherapy) without limitations in gait or balance independent living in the community cardiological stress test with cardiac or hemodynamic problems
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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): 30.0-999.0, Ventricular Tachycardia Patients with structural heart disease (ischemic and non-ischemic cardiomyopathy, previous surgery for congenital heart disease) Implanted ICD or CRT-D (cardiac resynchronization therapy defibrillator) Prior ≥1 catheter ablation procedure for monomorphic VT VT recurrence early (<12 months) after the last ablation with at least 2 episodes of recurrent VT, including 1 episode while on amiodarone (if not contraindicated) Age ≥30 years Signed an IRB-approved (Institutional Review Board) written informed consent Acute myocardial infarction or recent percutaneous coronary intervention (PCI) or cardiac surgery (<3 months) Primary electrical disease (channelopathy) Reversible cause of VT (e.g. drug-induced, intoxications, etc) Pregnancy or breastfeeding Chronic heart failure New York Heart Association (NYHA) Class IV Serious comorbidities with presumed life expectancy less than one year Significant peripheral artery disease precluding retrograde aortic mapping History of chest radiotherapy
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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, Ventricular Arrythmia diagnosed as ventricular arrhythmia resulted by structural heart diseases, including ischemic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, dilated cardiomyopathy, hypertrophic cardiomyopathy, etc none
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Heart Failure CT Angiography Ischemic Cardiomyopathy Non-ischemic Cardiomyopathy Heart Failure, Systolic Heart Failure，Congestive Heart Failure, Diastolic Heart Rate Low Sinus rhythm Heart rate >60/min Atrial fibrillation Any contraindication for beta-blocker use
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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, Premature Ventricular Complex Ventricular Arrythmia Patients with PVCs or VT requiring EPS for Symptomatic arrhythmias High PVC burden Presence of cardiomyopathy Risk stratification to determine which patients to offer ablative vs medical therapy and for ICD implantation if deemed high risk for sudden cardiac death Patients in acute coronary syndrome Patient with congestive heart failure in acute decompensation Patients in rapid atrial fibrillation Patients requiring persistent ventricular pacing Patient who refuse to undergo EPS
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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): 16.0-999.0, Blood Donors To be eligible for in this study, the individual must have presented to donate blood at a New York Blood Center high school blood drive where data is being collected and have passed the health screening process Less than 16 years of age; inability to read and comprehend English
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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, Post-myocardial Infarction Ventricular Tachycardia post-myocardial infarction ventricular tachycardia diagnosis scheduled to undergo radiofrequency catheter ablation as either emergency or elective case Unable to perform pace mapping during ablation procedure Unable to terminate VT thus unable to provide data regarding successful ablation lesion sites Intracardiac thrombus
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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): 19.0-999.0, Ischemic Ventricular Tachycardia (VT) greater than 18 years of age Ischaemic heart disease and prior myocardial infarction (using the international definition of MI: Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non-ischemic cause with documentation of prior ischaemic injury) Eligible for catheter ablation as standard of care Implantable Cardioverter Defibrillator Unable or unwilling to provide consent Both mechanical aortic and mitral valve LV thrombus NYHA class IV heart failure symptoms Contraindication to heparin Survival limited to <1 year in estimation of attending care team Prior VT ablation to standard of care VT catheter ablation procedure such as Active ischaemia (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 thought to be due to acute coronary arterial thrombosis, 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 Non-ischaemic cardiomyopathy because of reduced ablation success and PEFA has not been examined in the context of a non-ischaemic cardiomyopathy
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0
|
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 Over 18 years Diagnosis of neurally mediated syncope with a tilting table test (Tilt test) that demonstrates a mixed (type 1) or cardioinhibitory response (Type 2A and 2B) Negative impact on work and social life Non-respondent to pharmacological therapy (Fludrocortisone 0.1mg / 24 hours for 3 months) and non-pharmacological (exercise, hydration and consumption of more than 3 months) is due to a cardiologist who has performed a strict stricture over time At least 2 episodes of syncope in the last year Complete atrioventricular block Second degree ventricular atrial block Bradycardia syndrome tachycardia Disease of the sinus node Arrhythmia (bradycardia or tachycardia that generate syncope and / or low cardiac output) Syncope due to hypersensitivity of the carotid sinus Syncope with Tilt Test that demonstrates depressant vasopressor response (type 3) Refusal of the patient, his relatives or the attending physician to participate 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): 0.0-90.0, Ventricular Arrythmia diagnosed as Brugada syndrome(Brs)、Long QT syndrome(LQTS)、Short QT syndrome(SQTS)、Early repolarization syndrome(ERS) or Catecholaminergic polymorphic ventricular tachycardia(CPVT) patients were enrolled by other clinical trials
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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, Hip Osteoarthritis Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery Those presenting with disease that meets the indications for use for Medacta USA implants defined by this study (on-label use) Patients must be willing to comply with the pre and post-operative evaluation schedule Those with one or more medical conditions identified as a contraindication defined by the labeling on any Medacta implants used in this study
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0
|
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, Sarcoidosis Cardiac Sarcoidosis Boeck's Disease Besnier-Boeck Disease Diagnosis of sarcoidosis as per The American Thoracic Society guidelines 2. First visit to the enrolling center 3. Intent to continue care at the enrolling center at least annually Referred to the enrolling center to evaluate for suspected cardiac sarcoidosis. 2. Pre-existing high suspicion for cardiac sarcoidosis, defined as having had cardiac MRI or cardiac PET scan, even if it was ordered by other institutions. 3. Severe sarcoidosis or other disease conferring a high likelihood of death or transplant within the next year 4. Unwilling or unable to undergo echocardiography and ambulatory ECG
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0
|
65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 0.0-999.0, Syncope, Vasovagal At least one documented spontaneous VVS during preceding 12 months or one syncope in history leading to injury and minimum 2 presyncopal events during preceding 12 months, refractory to all recommended types of standard treatment In case of lack of ECG documentation during spontaneous syncope and history suggesting reflex syncope, at least 3 seconds of asystole due to sinus arrest or atrio-ventricular block with syncope or bradycardia <40 beats per minute with syncope or presyncope during baseline tilt test Sinus rhythm during ECG and tilt test Significantly decreased quality of life due to syncope Positive response to atropine test Obtained written informed consent Other possible and treatable causes of syncope such as significant cardiac disease, cardiac arrhythmia or abnormalities of vertebro-basiliar arteries History of stroke or TIA History of cardiac surgery Contraindications to ablation in the right or left atrium
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0
|
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, Telemetry Usage Chest Pain Unstable Angina Resource Utilization Adult ED patients admitted to the medical service at Vanderbilt University Medical Center with chest pain and low-risk clinical features Age less than 18 years Chest pain patients admitted to the ICU Patients with sickle cell disease Chest pain patients with high-risk electrocardiogram (ECG) abnormal but non-diagnostic of myocardial ischemia (prolonged PR, QRS, QTc intervals, new bundle branch blocks, left ventricular hypertrophy with strain) ischemia or prior infarction suggestive of acute myocardial infarction A positive troponin at any time during the current evaluation (above the 99 percent reference limit, greater than 0.03 nanograms per milliliter) Patients whom the admitting team feels has another non-low-risk indication for telemetry (e.g. acute heart failure, syncope with features concerning for a cardiac etiology, other arrhythmia)
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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): 40.0-999.0, Chest Pain Men and women age ≥ 40 years of age Stable chest pain or equivalent symptoms Planned non-urgent, non-invasive testing for diagnosis of chest pain or equivalent symptoms Acute coronary syndrome, including acute myocardial infarction or unstable angina, known non-ischemic cardiomyopathy or other cardiac disease (e.g. mitral valve prolapse, etc.) which would require urgent cardiac evaluation Known CAD Prior cardiac evaluation for current episode of symptoms Previously investigated for CAD in the last 12 months Severe allergic reaction to iodinated contrast (mild reactions such as urticaria that can be controlled by premedication with Benadryl & Prednisone may be included in the study) Renal failure or dysfunction (estimated Glomerular Filtration Rate<30ml/min/m2 within the past 3 months) Pregnancy (status will be confirmed verbally. For premenopausal patients who are unsure, status will be confirmed by completing a pregnancy strip test)
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0
|
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, Neurocognitive Dysfunction Men and women ≥ 18 years of age 2. Planned/scheduled endocardial ventricular tachycardia (VT) or premature ventricular contraction (PVC) catheter ablation procedure 3. For this patient, the current plan of the operator must be to pursue a catheter ablation target in the left ventricular endocardium that can be accessed by either a transseptal puncture or retrograde aortic approach 4. Life expectancy of at least 1 year 5. Willing and able to undergo pre and post-ablation MRIs 6. Willing and able to return and comply with scheduled follow up visits (through the 6 month follow-up) 7. Willing and able to provide written informed consent Planned epicardial ablation that would a coronary angiogram (during the index ventricular tachycardia (VT) or premature ventricular contraction (PVC) catheter ablation procedure) 2. Any contraindication to MRI (as defined by the institution performing the MRI) 3. Clinical contraindication to a retrograde aortic approach as determined by the treating physician, including: 1. Severe Aortic stenosis 2. Mechanical aortic valve 4. Clinical contraindication to a transseptal puncture as determined by the treating physician , including: 1. Severe Mitral valve stenosis 2. Mechanical Mitral valve 3. ASD or PFO closure device that would preclude a transseptal puncture 4. Mitraclip or Alfieri mitral valve repair that would preclude a transseptal puncture 5. Planned or known need to perform either a retrograde aortic approach or transseptal approach (such as to target another site during the same procedure) 6. Inability to speak, read, and write in the English language at a 6th grade level (required for the Neurocognitive Function Testing) 7. Current mental impairment or other diagnosis which precludes accurate assessment of neurocognitive function or which may not allow patient to understand the nature, significance and scope of the study 8. Inability to perform neurocognitive function testing after > 24 hours free of sedating medications
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0
|
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): 0.25-999.0, Chronic Thromboembolic Pulmonary Hypertension Pulmonary Arterial Hypertension Patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension diagnosed after 1st March 2018 (incident cases) who are aged > 3 months at the time of enrollment fulfill the following hemodinamic mean pulmonary arterial pressure (mPAP) of 25 mm Hg or more, mean pulmonary arterial wedge pressure (PAWP) or left ventricular end-diastolic pressure (PVEDP) of 15 mm Hg or less, pulmonary vascular resistance (PVR) of 3 Woods. Patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension diagnosed before 1st March 2018 (prevalent cases) who are aged > 3 months at the time of enrollment fulfill the following hemodinamic mean pulmonary arterial pressure (mPAP) of 25 mm Hg or more, mean pulmonary arterial wedge pressure (PAWP) or left ventricular end-diastolic pressure (PVEDP) of 15 mm Hg or less, pulmonary vascular resistance (PVR) of 3 Woods
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0
|
65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 50.0-999.0, Syncope years old syncope (defined in 2017 ACC/AHA/HRS guidelines[16]) in the prior 12 months diagnosis unclear after history, physical exam andelectrocardiogram no apparent risk of death due to the cause of syncope inability to give informed consent unable to attend routine follow up in device clinic positive carotid sinus massage
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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): 18.0-100.0, Brugada Syndrome Cardiac Arrest Athletes Heart Atrial Fibrillation Ventricular Ectopic Beat Patients with Brugada syndrome requiring risk stratification 2. Patients without Brugada syndrome acting as a control group 1. Patients undergoing ablation with ECGi system for other arrhythmias 2. Patient with AF undergoing ablation with ECGi system 3. Relatives of Brugada patients with confirmation of no pathology 4. Out-of-hospital cardiac arrest primary PCI with full recovery of left ventricular function and full revascularisation (n=10) 5. Athletic Hypertrophy (n=10) Pregnancy or not using a highly effective form of contraception 2. Patients unable to exercise 3. Patients unable to provide consent 4. Patients who have contraindications to an electrophysiological study. 5. Patients with no Brugada syndrome that are known to be high-risk for SCD for another reason e.g. Hypertrophic cardiomyopathy, ischaemic cardiomyopathy with severely impaired left ventricular function
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Cardiac Arrhythmia Male or female patients >18 years lead ECG finding of arrhythmia, manifest pre-excitation, pacing rhythm (in the EP lab), sinus rhythm or sinus tachycardia Age <18 years Patients unable to or unwilling to use the device Patients with cardiac pacemaker, ICDs, or other implanted electronic devices
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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 Tachycardia Ischemic Heart Disease Patients with coronary artery disease and ischaemic cardiomyopathy requiring ICD implantation for primary or secondary prevention. 2. Any episode of VT detected or treated appropriately (within monitor zone or therapy (ATP/shock) delivered) or by 12 lead ECG if the rate below the detection level of the device. An episode of VT will be defined as lasting more than 30 secs or a regular high rate episode meeting VT criterion for >50% of the time before the first therapy is delivered (i.e. VT degenerating into VF is acceptable under these circumstances). 3. Ablation or medical therapy would be considered reasonable option for ongoing management. 4. Males or females 18 years of age. 5. Suitable candidate for catheter ablation. 6. Signed informed consent Contraindication to catheter ablation. 2. VT due to reversible causes. 3. Severe valvular disease or ventricular thrombus. 4. Active gastrointestinal bleeding. 5. Serum Creatinine >200μmol/L or on dialysis. 6. Active fever or infection. 7. Life expectancy shorter than the duration of the trial. 8. Allergy to contrast. 9. Intractable heart failure (NYHA Class IV). 10. Bleeding or clotting disorders or inability to receive heparin. 11. Malignancy needing surgery, chemotherapy or radiotherapy. 12. Pregnancy or women of child-bearing potential not using a highly effective method of contraception. 13. Unable to attend follow-up visits or ICD clinics
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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 Arrythmia Infarction, Myocardial More than 18 yearts Chronic myocardial infarction Undergoing ventricular ablation of ventricular arrhythmias patients with device not suitable for cardiac magnetic ressonance (CMR) pregnacy
|
2
|
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 Fibrillation Ventricular Tachycardia All races and ethnicity (>18 years) Written informed consent form (ICF) has to be obtained from the patient Elective surgery: cardiac surgery on pump (CPB) Coronary artery bypass surgery Heart valve repair and/or replacement Mini sternotomy Median sternotomy Redo surgery Patients without cardiopulmonary bypass (referred to as heart-lung machine or pump) Emergency surgery without a sufficient amount of time to explain and ask for ICF
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0
|
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 ≥ 3 episodes of VT in 24 hours Pregnancy Implanted ventricular assist device Metal implanted in head or neck (except the mouth) Implanted medication pumps Cochlear implant Implanted brain stimulator Ocular implant History of malignancy in region of stimulation (neck)
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0
|
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, Critical Limb Ischemia Age >= 18 years Patients with clinical evidence of critical limb ischemia that are candidates for revascularization treatment A negative urine or serum pregnancy test in women of child-bearing age Ability to provide written informed consent to participate in the study Contraindication for MR as per current institutional guidelines Inability to lie supine for at least 30 minutes Pregnant or breastfeeding Unable or unwilling to provide informed consent Impending amputation within 6 weeks of presentation Previous metallic hardware in the lower limbs Unable to have ethanol
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0
|
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.
|
eligible ages (years): 18.0-999.0, Stereotactic Radioablation for Ventricular Tachycardia years of age and have an implanted cardioverter defibrillator (ICD) with: 1. Structural heart disease: ischemic or non-ischemic cardiomyopathy diagnosed with cardiac imaging demonstrating either segmental myocardial dysfunction, or presence of scar. 2. At least one of the following monomorphic VT events despite prior attempted catheter ablation (or contraindication for ablation), and despite treatment with a class III antiarrhythmic drug (contraindicated, ineffective or not tolerated): A: Sustained monomorphic VT documented on 12-lead ECG or rhythm strip terminated by pharmacologic means, DC cardioversion or manual ICD Therapy. B: ≥3 episodes of monomorphic VT treated with antitachycardia pacing (ATP), at least one of which was symptomatic C: ≥ 5 episodes of monomorphic VT treated with antitachycardia pacing (ATP) regardless of symptoms D: ≥1 appropriate ICD shocks, E: ≥3 monomorphic VT episodes within 24 hours VT events must be confirmed by ECG/monitor or ICD download Has received prior radiotherapy to the anticipated treatment field Pregnancy Unable to unwilling to provide informed consent New York Heart Association class IV heart failure or inotrope use limiting the safe transport to the radiotherapy suite Patients in whom the only ventricular arrhythmias are ventricular fibrillation, torsade de pointes, or polymorphic ventricular tachycardia Active coronary ischemia in the last 30 days
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2
|
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, Systolic Heart Failure Ventricular Premature Complexes Ventricular Tachycardia Cardiac Resynchronization Therapy Reduced Biventricular Pacing reduced biventricular pacing <98% due to ventricular arrhythmia reduced biventricular pacing <98% due to other cause age <18 pregnancy
|
2
|
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 Defibrillators, Implantable Patients with ICD and dilated cardiomyopathy or coronary heart disease as cause for implantation ICD implanted at St Olavs hospital, Trondheim In case of difficulties with patient for the study, the might be broadened to patients with idiopathic ventricular arrhythmia as cause for implantation inability to accomplish the exercise program due to serious comorbidity or to participate in regular training within the next 3 months due to other reasons signs of severe cardiac ischemia or persistent ventricular tachycardia during individualized treadmill O2 peak test, which after individual assessment is to be found at risk comorbidity where endurance training at more than moderate intensity is discouraged severe cardiac valve disease planned surgery within the next 3 months inability to give informed consent
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0
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