Clinical trials: Sudden Cardiac Arrest
Ventricular Tachycardia, Ventricular Fibrillation
DAVID II (Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial II)
The DAVID II Clinical Study evaluates the hypothesis that, in patients needing an ICD but without overt indications for pacing, AAI pacing with maximal concomitant drug therapy will not increase the rate of the combined endpoint…
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Sudden Cardiac Death, Congestive Heart Failure
- Trial name
- DAVIDII (NCT00187187)
- Testing
- Implantable Defibrillator (ICD)
- Volunteers
- 600 people
- Sponsor
- Abbott Medical Devices
Sudden Cardiac Death
POWER (Pulse Width Optimized Waveform Evaluation Trial)
The objective of this study is to compare the ULV (Upper Limit of Vulnerability)/DFT (Defibrillation Threshold) efficacy between the 2.5, 3.5 and 4.5 ms membrane time constant based biphasic defibrillation waveforms.
- Trial name
- NCT00311181
- Testing
- Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT-D)
- Where
- 2 sites in United States
- Volunteers
- 217 people
- Sponsor
- Abbott Medical Devices
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
Sudden Cardiac Arrest
ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS)
Active surveillance study using real-world data collected in the ASSURE Patient Registry. Outcome measures are based on analysis of ASSURE Registry data including data recorded by the WCD then annotated by clinical experts in…
- Trial name
- ACE-PAS (NCT05135403)
- Testing
- Defibrillation
- Where
- United States
- Volunteers
- 5,179 people
- Sponsor
- Kestra Medical Technologies, Inc.
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 Jewel IDE Study
The Jewel IDE Study: A Clinical Evaluation of the Jewel P-WCD in Subjects at High Risk for Sudden Cardiac Arrest. ("JEWEL")
- Trial name
- NCT05201495
- Testing
- Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)
- Where
- 30 sites in United States
- Volunteers
- 322 people
- Sponsor
- Element Science, Inc.
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
Tachyarrhythmias, Sudden Cardiac Death
SJ4 Post Approval Study in Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Defibrillator Patients
The purpose of this study is to characterize the chronic performance of the St. Jude Medical SJ4 connector and RV high voltage SJ4 leads.
- Conditions
- Tachyarrhythmias, Sudden Cardiac Death, Heart Failure
- Trial name
- NCT00940888
- Testing
- SJ4 connector and RV high voltage SJ4 lead
- Where
- United States
- Volunteers
- 1,701 people
- Sponsor
- Abbott Medical Devices
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, Heart Failure With Reduced Ejection Fraction
Assessment of Combined CCM and ICD Device in HFrEF
The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D System (the "CCM-D System") can safely and effective convert induced ventricular fibrillation (VF) and spontaneous ventricular tachycardia and/or…
- Conditions
- Heart Failure, Heart Failure With Reduced Ejection Fraction, Implantable Defibrillator User, CCM Therapy
- Trial name
- INTEGRA-D (NCT05855135)
- Testing
- OPTIMIZER® Integra CCM-D System (Treatment Arm)
- Where
- 59 sites in United States
- Volunteers
- 300 people
- Sponsor
- Impulse Dynamics
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.
Sudden Cardiac Arrest
HeartStart FRx Defibrillator Event Registry
This post market clinical follow-up study is a multi-center, non-randomized, unblinded, observational registry of the performance of the FRx Automated external defibrillator (AED) used in conjunction with electrodes with or…
- Trial name
- NCT04250857
- Testing
- HeartStart FRX
- Where
- United States
- Volunteers
- 1,400 people
- Sponsor
- Heartstream US LLC
Bradycardia, Sudden Cardiac Arrest
Feasibility Study of Remote Support for Implantable Pulse Generator (IPG)/Implantable Cardioverter Defibrillator (ICD) Implant
The purpose of this study is to gain real world, live implant experience with the remote implant support system. This system is intended to provide the technical support for device implants from a remote location through…
- Trial name
- NCT01809652
- Testing
- Remote Implant Support Capability
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Sudden Cardiac Arrest, Emergency Care
Tempus Pro Monitor Registry
A multicenter, prospective and retrospective, observational, post market study.
- Trial name
- NCT05587764
- Testing
- Standard of Care
- Where
- United States
- Volunteers
- 103 people
- Sponsor
- Heartstream US LLC
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
Ventricular Tachycardia, Ventricular Fibrillation
DF4 Master Study (Safety and Efficacy Study)
The purpose of the study is to proof the safety and efficacy of the new ICD sytem (Iforia/Ilesto). The devices are available with DF-1 and DF4 connection. A special focus is set on the ICD system with DF4 connection.
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Sudden Cardiac Death, Heart Failure
- Trial name
- NCT01790841
- Testing
- Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego
- Where
- Germany
- Volunteers
- 240 people
- Sponsor
- Biotronik SE & Co. KG
Sudden Cardiac Death, Sudden Cardiac Arrest
Heart Failure Optimization Study
This study is designed as a multi-center prospective observational study of newly diagnosed Heart Failure (HF) patients to test the hypothesis that additional Ejection Fraction (EF) recovery occurs between 90 and 180 days as…
- Conditions
- Sudden Cardiac Death, Sudden Cardiac Arrest, Heart Failure, Heart Failure Low Output
- Trial name
- HF-Opt (NCT03016754)
- Testing
- Wearable Cardioverter Defibrillator
- Where
- 67 sites in United States, Austria and 2 more
- Volunteers
- 602 people
- Sponsor
- Zoll Medical Corporation
Cardiac Death
Reduction of Inappropriate Implantable Cardioverter Defibrillator (ICD) Therapies in Primary Prevention Patients
The purpose of this study is to determine efficacy of a dedicated programming concept for avoidance of inappropriate implantable cardioverter defibrillator (ICD) therapies in patient with primary prevention ICD indication.
- Trial name
- DECREASE (NCT01217528)
- Testing
- device settings for group A, Device settings for group B
- Where
- 34 sites in Germany
- Volunteers
- 543 people
- Sponsor
- Abbott Medical Devices
Ventricular Fibrillation, Ventricular Flutter
SAFEty of Two Strategies of ICD Management at Implantation
The aim of this prospective observational study is to evaluate the safety, over a follow-up of 2 years, of two strategies, consisting in performing or not performing defibrillation testing(DT) during first implant of implantable…
- Conditions
- Ventricular Fibrillation, Ventricular Flutter, Sudden Cardiac Death
- Trial name
- SAFE-ICD (NCT00661037)
- Testing
- Implantable defibrillator
- Where
- Italy
- Volunteers
- 2,120 people
- Sponsor
- Boston Scientific Corporation
Heart Failure, Sudden Cardiac Death
Longitudinal Surveillance Registry
Boston Scientific CRM's Longitudinal Surveillance Registry (LSR) will serve as an active ongoing source of updated information on the long-term reliability and performance of BSC commercially available leads and LATITUDE-enabled…
- Trial name
- LSR (NCT00636272)
- Volunteers
- 2,500 people
- Sponsor
- Boston Scientific Corporation