Clinical trials: Implantable Cardioverter-Defibrillator
Atrial Fibrillation, Arrythmia
Arrythmia Burden in Cardiac Contractility Modulation (CCM)
The Impulse Dynamics Optimizer Device is a Food and Drug Administration (FDA) approved; commercially available device indicated for patients with heart failure with reduced ejection fraction (HFrEF).
- Trial name
- ABC (NCT05704426)
- Testing
- Impulse Dynamics Optimizer Device
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Hackensack Meridian Health
Complication of Cardiac Defibrillator
Health Economic Evaluation of Remote Follow up for Implantable Cardioverter Defibrillator (ICD) Patients
The purpose of the study is to define the economic value of implantable cardioverter defibrillator (ICD) remote monitoring for hospitals, third payers and patients in Italy.
- Trial name
- TARIFF (NCT01075516)
- Where
- 6 sites in Italy
- Volunteers
- 209 people
- Sponsor
- Abbott Medical Devices
Cardiomyopathy, Coronary Artery Disease
Efficacy and Safety of Implantable Cardioverter-Defibrillator (ICD) Implantation in the Elderly
The overall aim of this trial is to study the safety and efficacy of ICD implantation as a primary prevention strategy of sudden cardiac death in patients 70 years and older.
- Conditions
- Cardiomyopathy, Coronary Artery Disease, Congestive Heart Failure, Myocardial Infarction
- Trial name
- I-70 (NCT02121158)
- Testing
- Implantable Cardioverter Defibrillator, Optimal Medical Therapy
- Where
- 5 sites in United States
- Volunteers
- 167 people
- Sponsor
- VA Office of Research and Development
Defibrillators, Implantable, Tachycardia, Ventricular
Catheter Ablation Versus Amiodarone for Shock Prophylaxis in Defibrillator Patients With Ventricular Tachycardia
Implantable Cardioverter Defibrillators (ICDs) provide a shock or pacing therapy to bring back a normal heart beat when a patient experiences a dangerous abnormal heart rhythm such as ventricular tachycardia (VT).
- Trial name
- CEASE-VT (NCT01097330)
- Testing
- Ablation, Amiodarone
- Where
- 11 sites in United States, Canada and 1 more
- Volunteers
- 12 people
- Sponsor
- Population Health Research Institute
Implantable Defibrillator User
Protego DF4 Post Approval Registry
The purpose of this registry study is to confirm the long-term safety and reliability of the Protego DF4 right ventricular lead.
- Trial name
- NCT02243696
- Where
- 68 sites in United States
- Volunteers
- 1,694 people
- Sponsor
- Biotronik, Inc.
Implantable Defibrillator
Confirmatory Clinical Trial of the Evera MRI System for Conditionally-safe MRI Access
The purpose of the Evera MRI™ study is to confirm safety and efficacy of the Evera MRI ICD (Implantable cardioverter-defibrillator) System in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI…
- Trial name
- NCT02117414
- Testing
- MRI scan sequences of the head and chest regions, Waiting Period Visit
- Where
- 42 sites in United States, Belgium and 11 more
- Volunteers
- 275 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradycardia, Tachycardia
Randomized Study of the Use of Warfarin During Pacemaker or ICD Implantation in Patients Requiring Long Term Anticoagulation
Patients requiring long term anticoagulation often undergo transition of their warfarin to heparin in anticipation of invasive surgical procedures such as pacemaker or ICD implantation.
- Conditions
- Bradycardia, Tachycardia, Atrial Fibrillation, Valvular Heart Disease
- Trial name
- NCT00721136
- Testing
- continue warfarin through the procedure, Hold warfarin, Warfarin held with heparin transition.
- Where
- 2 sites in United States
- Volunteers
- 104 people
- Sponsor
- Johns Hopkins University
Tachycardia
Safety and Performance Study of the Reliance 4-Front Lead
The objective of this study is to gather data to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONT™ Active Fixation Defibrillation Leads.
- Trial name
- NCT01772576
- Testing
- Reliance 4-Front lead implantation
- Where
- 15 sites in Austria, China and 9 more
- Volunteers
- 167 people
- Sponsor
- Boston Scientific Corporation
Anxiety, Depression
Psychological Support for Patients With an Implantable Cardioverter Defibrillator
About 30% of patients survive a cardiac arrest, and the majority of these receive an implantable cardioverter defibrillator (ICD) for prevention of sudden cardiac death (SCD).
- Trial name
- NCT00152763
- Testing
- Cognitive Behaviour Therapy (CBT), Usual Cardiac Care (UCC)
- Where
- Canada
- Volunteers
- 193 people
- Sponsor
- University Health Network, Toronto
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
Sudden Cardiac Death, Heart Failure
Educational Videos to Address Racial Disparities in Implantable Cardioverter Defibrillator Therapy
VIVID is a prospective, multicenter, randomized clinical trial in African American patients that will to evaluate: (1) the effect of an educational video on knowledge of sudden cardiac death (SCD) and implantable cardioverter…
- Trial name
- VIVID (NCT02819973)
- Testing
- Educational Video1, Educational Video 2, Usual Care 3
- Where
- 14 sites in United States
- Volunteers
- 343 people
- Sponsor
- Duke University
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
Arrhythmogenic Right Ventricular Cardiomyopathy
Pilot Randomized Trial With Flecainide in ARVC Patients
Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) is an inherited arrhythmia disorder with high risk of ventricular tachycardia or fibrillation, and implantable cardioverter defibrillator remains as therapy of choice.
- Trial name
- NCT03685149
- Testing
- Flecainide Pill
- Where
- 6 sites in United States
- Volunteers
- 22 people
- Sponsor
- University of Rochester
Heart Failure
Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy Post Approval Registry
MADIT-CRT PAR is an FDA mandated follow-up registry for patients that participated in the MADIT-CRT IDE study examining long-term mortality. (MADIT-CRT IDE: NCT00180271)
- Trial name
- MADIT-CRT PAR (NCT01294449)
- Testing
- MADIT-CRT ICD, MADIT-CRT CRT-D
- Where
- United States
- Volunteers
- 394 people
- Sponsor
- Boston Scientific Corporation
Tachycardia, Ventricular
Boston Scientific Post Market Subcutaneous-Implantable Cardioverter Defibrillator (S-ICD) Registry
The EFFORTLESS ICD Registry is an observational, standard of care evaluation designed to demonstrate the early, mid and long-term clinical effectiveness the Boston Scientific S-ICD System.
- Trial name
- EFFORTLESS (NCT01085435)
- Testing
- S-ICD System
- Where
- 44 sites in Czechia, Denmark and 8 more
- Volunteers
- 994 people
- Sponsor
- Boston Scientific Corporation
Heart Disease, Cardiovascular Disease
Remote Device Interrogation In The Emergency Department
A prospective, post market, non-randomized study to evaluate the reduction in time to interrogation for patients with St. Jude Medical remote care compatible devices interrogated by the unpaired Merlin@home transmitter in the…
- Conditions
- Heart Disease, Cardiovascular Disease, Heart Failure, Arrhythmias, Cardiac
- Trial name
- REMEDY (NCT01871090)
- Testing
- Unpaired remote monitoring transmitter
- Where
- United States
- Volunteers
- 99 people
- Sponsor
- Abbott Medical Devices
Tachycardia, Ventricular
Bispectral Index Monitoring During Testing in the Electrophysiology Lab
BACKGROUND Physician-guided moderate sedation, administered by a Registered Nurse has been the standard of practice for patients undergoing a wide range of electrophysiology procedures during the past decade.
- Trial name
- NCT00749671
- Testing
- Bispectral index monitoring, Ramsey Sedation Scale
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Baystate Medical Center
Ischemic Cardiomyopathy, Nonischemic Cardiomyopathy
Ranolazine Implantable Cardioverter-Defibrillator Trial
The purpose of the study is to see how effective a drug called ranolazine is in reducing the risk of ventricular arrhythmia and death in people with implantable cardioverter-defibrillators (ICDs).
- Conditions
- Ischemic Cardiomyopathy, Nonischemic Cardiomyopathy, Heart Failure
- Trial name
- RAID (NCT01215253)
- Testing
- Ranolazine
- Where
- 90 sites in United States, Canada
- Volunteers
- 1,012 people
- Sponsor
- University of Rochester
Ventricular Tachycardia, Ischemic
Early Ablation Therapy for the Treatment of Ischemic Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillators
The purpose of this study is to determine if early ablation (i.e., ablation of ventricular tachycardia in patients with infrequent VT episodes) is more effective than medical therapy alone for the treatment of ischemic…
- Trial name
- ASPIRE (NCT01557842)
- Testing
- Drug Treatment, Catheter Ablation
- Where
- 23 sites in United States
- Volunteers
- 15 people
- Sponsor
- Biosense Webster, Inc.