Clinical trials: Sudden Cardiac Death
Sudden Cardiac Death
Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP
The primary objective is to understand the role of antitachycardia pacing (ATP) in primary prevention patients indicated for implantable cardioverter-defibrillator (ICD) therapy and programmed according to current guidance of…
- Trial name
- APPRAISE ATP (NCT02923726)
- Testing
- Arm 1 (ATP+Shock), Arm 2 (shock only)
- Where
- 134 sites in United States, Austria and 6 more
- Volunteers
- 2,692 people
- Sponsor
- Boston Scientific Corporation
Death, Sudden, Cardiac, Ventricular Fibrillation
Medtronic Genetic Arrhythmia Markers for Early Detection (GAME Study)
To generate a list of potential genetic markers that correlate with an increased risk of life-threatening arrhythmias. To evaluate ECG-based risk markers such as heart rate variability and T-wave Alternans for their association…
- Conditions
- Death, Sudden, Cardiac, Ventricular Fibrillation, Tachycardia, Atrial Fibrillation
- Trial name
- GAME (NCT00664807)
- Where
- United States
- Volunteers
- 1,023 people
- Sponsor
- Medtronic Corporate Technologies and New Ventures
Ischemic Heart Failure
LifeVest Wearable Cardioverter Defibrillator WEARIT-III Registry
The WEARIT-III registry enrolls subjects with ischemic cardiomyopathy and heart failure (including NYHA II, III, IV and an ejection fraction ≤ 35%) who wear a medically prescribed ZOLL LifeVest Wearable Defibrillator.
- Trial name
- WEARIT-III (NCT02700880)
- Testing
- LifeVest
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Zoll Medical Corporation
Cardiac Arrest, Sudden
AED Log Analysis of 19 Cases in Out-of-hospital Environment
The study performed to demonstrate a reasonable assurance of safety and effectiveness of the Heart Guardian HR-501 when used in an out-of-hospital environment.
- Trial name
- NCT03969797
- Testing
- RADIAQBIO Heart Guardian HR-501
- Where
- South Korea
- Volunteers
- 19 people
- Sponsor
- RadianQbio
Sudden Cardiac Death
Prospective Study to Identify Patients at Risk of Dangerous Ventricular Arrhythmias
The purpose of this study is to determine how well the device predicts susceptability to potentially lethal ventricular arrhythmias.
- Trial name
- HIP (NCT00562757)
- Where
- 8 sites in United States, Germany and 2 more
- Volunteers
- 320 people
- Sponsor
- Harbinger Medical, Inc.
Ventricular Tachycardia, Ventricular Fibrillation
DF4 Connector System Post-Approval Study
The purpose of this study is to evaluate long-term performance of the DF4 Connector System. This evaluation is based on the number of DF4 lead-related complications occurring during the study compared to the number of leads…
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Sudden Cardiac Death, Heart Failure
- Trial name
- NCT01638897
- Where
- 78 sites in United States, Canada and 1 more
- Volunteers
- 1,778 people
- Sponsor
- Medtronic
Death, Sudden, Cardiac
ASSURE WCD Clinical Evaluation - Conversion Efficacy Study
A multicenter single arm open label evaluation of the ASSURE Wearable Cardioverter Defibrillator (WCD) defibrillation waveform in adult cardiac patients
- Trial name
- ACE-CONVERT (NCT04132466)
- Testing
- Defibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test system
- Where
- 4 sites in United States
- Volunteers
- 13 people
- Sponsor
- Kestra Medical Technologies, Inc.
Arrhythmogenic Cardiomyopathy, PKP2-ACM
Long-term Follow-up Study of Gene Therapy for Arrhythmogenic Cardiomyopathy Due to a Plakophilin-2 Pathogenic Variant
The primary objective of this Phase 1/2 long-term follow-up (LTFU) study is to assess the long-term safety and tolerability of LX2020 for the treatment of arrhythmogenic cardiomyopathy (ACM) due to a plakophilin-2 gene (PKP2)…
- Conditions
- Arrhythmogenic Cardiomyopathy, PKP2-ACM, PKP2-ARVC
- Trial name
- GRIT-PKP2 (NCT07050160)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Lexeo Therapeutics
Heart Failure, Sudden Cardiac Death
CORE: Study to Evaluate the Conducted AF-Response-Algorithm in Patients Suffering From Heart Failure and Atrial Fibrillation
The Medtronic InSync III Marquis Cardiac Resynchronization Therapy Defibrillator (CRT-D)-System (implantable cardioverter-defibrillator with biventricular stimulation for cardiac resynchronization) is equipped with the…
- Conditions
- Heart Failure, Sudden Cardiac Death, Atrial Fibrillation
- Trial name
- NCT00170313
- Testing
- Conducted AF-Response Algorithm (CAFR) On, Conducted AF-Response Algorithm (CAFR) Off
- Where
- 7 sites in Germany
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
Trial to Determine Imaging Parameters of LMI1195 in Heart Failure Patients at Low and High Risk of Defibrillator Firing
The purpose of this clinical study is to determine the optimal imaging parameters and assess the safety of LMI1195 -101 in Heart Failure subjects at Low and High Risk of cardiac events.
- Trial name
- LMI1195-201 (NCT01085175)
- Testing
- LMI 1195
- Where
- United States
- Sponsor
- Lantheus Medical Imaging
Heart Failure, Ventricular Dysfunction
Study of the Wearable Defibrillator in Heart-Failure Patients
The purpose of the study is to evaluate the safety and efficacy of wearable defibrillator use in patients with left ventricular dysfunction or advanced heart failure symptoms, who have a high-risk for sudden cardiac death but are…
- Conditions
- Heart Failure, Ventricular Dysfunction, Sudden Death, Sudden Cardiac Arrest
- Trial name
- SWIFT (NCT01326624)
- Testing
- wearable defibrillator (LifeVest)
- Where
- 2 sites in United States, Israel
- Volunteers
- 25 people
- Sponsor
- Zoll Medical Corporation
Primary Prevention of Sudden Cardiac Arrest, Secondary Prevention of Sudden Cardiac Arrest
S-ICD® System Post Approval Study
The purpose of the S-ICD Post Approval Study is to document long term safety and effectiveness outcomes associated with the implantation of the SQ-RX pulse generator and Q-TRAK electrode in a commercial clinical setting.
- Trial name
- NCT01736618
- Testing
- S-ICD System
- Where
- 87 sites in United States
- Volunteers
- 1,766 people
- Sponsor
- Boston Scientific Corporation
Sudden Cardiac Arrest, Acute Myocardial Infarction
Improve SCA Bridge Study
The purpose of the Improve SCA Bridge study is to characterize the care pathway flow of post-acute myocardial infarction (MI) patients as a result of standard assessments of left ventricular ejection fraction (LVEF) in the acute…
- Trial name
- NCT03715790
- Testing
- EP referred group, Non-Referred group
- Where
- 52 sites in Bangladesh, Brunei and 14 more
- Volunteers
- 1,491 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiac Arrest, Sudden Cardiac Death
Hemodynamic Effects of Standard Cardiopulmonary Resuscitation (CPR), Active Compression Decompression CPR With an Inspiratory Impedance Device, and Standard CPR With an Intrathoracic Pressure Regulator During Out-of-hospital Cardiac Arrest
More than 300,000 Americans experience out-of-hospital cardiac arrest annually, with overall survival rates averaging less than 5%.
- Trial name
- NCT01325870
- Testing
- ACD-CPR, ITPR, S-CPR
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Advanced Circulatory Systems
Sudden Cardiac Death, Sudden Cardiac Arrest
Effects of Stearidonic Acid-Containing Foods on Eicosapentaenoic Acid Levels in Red Blood Cells and Omega-3 Index
The purpose of this study is to assess the effect of stearidonic acid when used as a food ingredient on eicosapentaenoic enrichment of red blood cell membranes and Omega-3 Index in men and women.
- Conditions
- Sudden Cardiac Death, Sudden Cardiac Arrest, Cardiovascular Disease
- Trial name
- NCT01749202
- Testing
- Sunflower Oil Softgels, EPA softgels, Sunflower Oil Food
- Where
- United States
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- Solae, LLC
Sudden Cardiac Arrest
The Intrepid Clinical Engineering Study
The purpose of this research study is to collect clinical data to validate a software update for 12-lead electrocardiogram monitoring.
- Trial name
- NCT05636332
- Testing
- 12 lead Electrocardiogram
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Heartstream US LLC
Syncope
Ambulatory Post-Syncope Arrhythmia Protection Feasibility Study
The purpose of this study is to conduct an observational investigation of a novel care path used to manage emergency department (ED) presenting syncope patients on an outpatient basis.
- Trial name
- ASAP (NCT02188147)
- Testing
- Short Term Wearable Defibrillator
- Where
- 6 sites in United States
- Volunteers
- 39 people
- Sponsor
- Zoll Medical Corporation
Sudden Cardiac Death, Heart Failure
Next Generation INCEPTA Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy (CRT-D) Field Following Study
This study has 2 purposes: The first purpose of the study is to test a new family of Boston Scientific Implantable Cardioverter Defibrillators ("ICDs") and cardiac resynchronization therapy ICDs ("CRT-Ds") and show how well these…
- Trial name
- NOTICE-HF (NCT01227785)
- Testing
- INCEPTA ICD or CRT-D
- Where
- Germany
- Volunteers
- 120 people
- Sponsor
- Guidant Corporation
Death, Sudden, Cardiac, Ventricular Fibrillation
DISCOVERY: Diagnostic Data and Genetic Polymorphisms in ICD Patients.
To prospectively evaluate if the analysis of genetic polymorphisms can be used to identify patients at risk of ventricular tachycardia.
- Conditions
- Death, Sudden, Cardiac, Ventricular Fibrillation, Tachycardia, Atrial Fibrillation
- Trial name
- DISCOVERY (NCT00478933)
- Testing
- Defibrillator, Dual Chamber ; Implantable, Blood sampling
- Volunteers
- 1,223 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Sudden Cardiac Death
Ovatio DR and VR Implantable Cardioverter Defibrillators Post-approval Study
The purpose of this post-approval study is to confirm the safety and effectiveness of Ovatio DR and VR ICDs
- Trial name
- Post-Ovatio (NCT00586378)
- Testing
- Ovatio DR and Ovatio VR
- Where
- United States
- Volunteers
- 85 people
- Sponsor
- ELA Medical, Inc.