Clinical trials: Defibrillators
Cardiomyopathy, Heart Failure
Evaluating Myocardial Injury for Defibrillation Threshold Testing Methods for ICD Implantation
The objective of this study is to evaluate myocardial injury, if any, as quantified by cardiac markers (Troponin-T) in defibrillation threshold (DFT) testing during implantation of implantable cardioverter defibrillators (ICDs)…
- Conditions
- Cardiomyopathy, Heart Failure, Cardiac Arrhythmia
- Trial name
- ULV (NCT02111993)
- Testing
- Standard Defibrillation Testing, Upper Limit of Vulnerability Testing
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of California, San Diego
Tachycardia, Ventricular Arrythmia
ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Japan Study
The study is designed to characterize the acute safety and performance of the EV ICD System for Japanese patients.
- Trial name
- NCT07091916
- Testing
- Defibrillation using the Extravascular ICD
- Where
- Japan
- Volunteers
- 14 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure, Systolic, Heart Failure
A Multicenter Trial of a Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-DEfibrillators
The investigators goal is to assess real-world effectiveness of patient decision aids (PtDA) for high-risk decisions using the implantable cardioverter-defibrillator (ICD) as a model.
- Trial name
- NCT03374891
- Testing
- Educational video and/or handout
- Where
- United States
- Volunteers
- 790 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Myocardial Infarction, Ventricular Dysfunction
Vest Prevention of Early Sudden Death Trial and VEST Registry
This study explores the hypothesis that wearable defibrillators can impact mortality by reducing sudden death during the first three months after a heart attack in persons with high risk for life-threatening arrhythmias.
- Conditions
- Myocardial Infarction, Ventricular Dysfunction, Sudden Death, Ventricular Tachycardia
- Trial name
- VEST (NCT01446965)
- Testing
- wearable defibrillator
- Where
- 71 sites in United States, Germany and 1 more
- Volunteers
- 2,348 people
- Sponsor
- University of California, San Francisco
Heart Failure
Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic Heart Failure (HF) (REDUCEhf)
The purpose of this clinical research study is to evaluate the safety and effectiveness of the investigational implantable hemodynamic monitor (IHM), and of the IHM in combination with an implantable cardioverter defibrillator…
- Trial name
- REDUCEhf (NCT00354159)
- Testing
- Implantable Hemodynamic Monitor (Chronicle® IHM), and IHM in combination with single chamber ICD (Chronicle ICD)
- Where
- 52 sites in United States
- Volunteers
- 442 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Wound, Cardiac Arrhythmia
ZIPS Study - Zip Incision aPproximation vs. Suture
ZipLine Medical, Inc. has developed a novel, non-invasive skin closure device called "Zip Surgical Skin Closure" to replace sutures, staples and glue for closure of the skin layer for surgical incisions or laceration repair.
- Trial name
- ZIPS (NCT02213510)
- Testing
- Zip Surgical Skin Closure Device, Standard Suture Closure
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of California, San Diego
Primary Prevention of Sudden Cardiac Arrest
Multicenter Automatic Defibrillator Implantation Trial - Reduce Inappropriate Therapy
This study will assess the impact of higher rate cutoffs and longer delays than standard programming on inappropriate therapy in primary prevention ICD and CRT-D patients.
- Trial name
- MADIT-RIT (NCT00947310)
- Testing
- Standard ICD programming, High rate cutoff, Long delay
- Where
- United States
- Volunteers
- 1,500 people
- Sponsor
- Boston Scientific Corporation
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
Electromagnetic Interference
Safety of Screening Procedures With Hand-held Metal Detectors Among Patients With Implanted Cardiac Rhythm Devices
Patients with implanted pacemaker (PM) or cardioverter-defibrillator (ICD) systems are restrained in daily life by possible electromagnetic interference (EMI).
- Trial name
- NCT01369706
- Testing
- Hand-held metal detector
- Where
- 2 sites in Germany, Greece
- Volunteers
- 388 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Heart Failure
International Study to Determine if AdreView Heart Function Scan Can be Used to Identify Patients With Mild or Moderate Heart Failure (HF) That Benefit From Implanted Medical Device
This is an event-driven Phase IIIb, multicentre, randomised, clinical study to demonstrate the efficacy of AdreView™ imaging for appropriately guiding the decision of implantable cardioverter defibrillator (ICD) implantation, in…
- Trial name
- ADMIRE-ICD (NCT02656329)
- Testing
- Iobenguane I -123 Injection, Implantable Cardioverter Defibrillator, Thyroid blocking
- Where
- 94 sites in United States, Canada and 8 more
- Volunteers
- 395 people
- Sponsor
- GE Healthcare
Tachycardia, Ventricular
S-ICD® System IDE Clinical Study
This clinical study is designed to evaluate the safety and effectiveness of the subcutaneous implantable defibrillator (S-ICD) System.
- Trial name
- NCT01064076
- Testing
- S-ICD System
- Where
- 33 sites in United States, Netherlands and 2 more
- Volunteers
- 330 people
- Sponsor
- Boston Scientific Corporation
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
Heart Disease
Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts III
To demonstrate a reduction in the number of ventricular therapies (ATP and Shocks) delivered for treating spontaneous arrhythmia episodes with a fast cycle length (CL≤ 320ms) as a consequence of self-termination and better…
- Trial name
- ADVANCEIII (NCT00617175)
- Testing
- Implantable Defibrillator
- Where
- 91 sites in Belgium, Denmark and 12 more
- Volunteers
- 1,902 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiomyopathy, Dilated, Arrhythmia
Mental Stress Reduction in Defibrillator Patients
The purpose of this study is to assess the effectiveness of a 10 week program of Stress Management versus control Patient Education sessions on cardiac responses to mental stress in veterans with Implantable…
- Conditions
- Cardiomyopathy, Dilated, Arrhythmia, Anger, Stress
- Trial name
- NCT00624520
- Testing
- Cognitive Behavioral Stress Management (CBSM), Patient Education
- Where
- 2 sites in United States
- Volunteers
- 129 people
- Sponsor
- US Department of Veterans Affairs
Heart Failure
Integrated Diagnostics Driven Diuretic and Chronic Medication Management for Heart Failure
The INTERVENE-HF study is a prospective, non-randomized, multi-center (US only), investigational, feasibility study. The purpose of this study is to characterize safety of managing heart failure patients with integrated device…
- Trial name
- NCT02698241
- Testing
- Diagnostic & Medication Management
- Where
- 8 sites in United States
- Volunteers
- 79 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Ventricular Arrhythmias
Antiarrhythmic Effects of Spironolactone in Patients With ICDs
This study will test whether spironolactone, an approved drug for among other things hypertension, will reduce the risk of severe arrhythmias in patients with implanted defibrillators.
- Trial name
- SPIRIT (NCT04495712)
- Testing
- spironolactone
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- VA Office of Research and Development
Tachycardia, Ventricular, Heart Failure, Congestive
OMNI Study--Assessing Therapies in Medtronic Pacemaker, Defibrillator, and Cardiac Resynchronization Therapy Devices.
The purpose of the OMNI study is to characterize therapy and diagnostic utilization in study participants implanted with study devices and to describe Implantable Cardioverter Defibrillator(ICD)therapy utilization for life…
- Conditions
- Tachycardia, Ventricular, Heart Failure, Congestive, Ventricular Fibrillation, Ventricular Dysfunction
- Trial name
- OMNI (NCT00277524)
- Where
- 113 sites in United States
- Volunteers
- 3,032 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Persistent Atrial Fibrillation, Cardiac Arrhythmia
Investigation of Therapeutic Ablation Versus Cardioversion for AF
The main aim of the research is to investigate whether patients undergoing pulmonary vein isolation with cryoablation for atrial fibrillation (AF) will have lower rates of AF recurrence than those treated by DC cardioversion…
- Trial name
- ORBITA-AF (NCT03907982)
- Testing
- DC Cardioversion, Pulmonary vein isolation, Implantable loop recorder
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Barts & The London NHS Trust
Death, Sudden, Cardiac, Ventricular Fibrillation
Automatic External Defibrillation Monitoring in Cardiac Arrest
We propose to randomize automatic external cardioverter/defibrillators (AECD) in patients who are at high risk for life-threatening abnormal heart rhythms (arrhythmias) and are admitted to the telemetry ward, all other treatments…
- Conditions
- Death, Sudden, Cardiac, Ventricular Fibrillation, Tachycardia, Ventricular
- Trial name
- NCT00382928
- Testing
- Defibrillation of pulseless VT/VF by AECD
- Where
- United States
- Volunteers
- 192 people
- Sponsor
- Foundation for Atlanta Veterans Education and Research, Inc.
Heart Failure
Promote Q Cardiac Resynchronization Therapy Defibrillator (CRT-D) and Quartet Left Ventricular Heart Lead Study
The objective of this study is to assess the safety and efficacy of the Quartet™ lead and Promote Q® device system in a patient population indicated for cardiac resynchronization therapy.
- Trial name
- Promote Q (NCT00990665)
- Testing
- CRT-D and LV lead (Quartet™ lead and Promote Q® device system)
- Where
- 24 sites in United States
- Volunteers
- 178 people
- Sponsor
- Abbott Medical Devices