Clinical trials: Defibrillators, Implantable
Ventricular Tachycardia, Ventricular Fibrillation
The Use of Dual Chamber ICD With Special Programmed Features to Lower the Risk of Inappropriate Shock
The RAPTURE Study will determine whether dual chamber defibrillators with atrial prevention and termination therapies, minimized ventricular pacing, and remote monitoring will reduce the rate of inappropriate shocks and improve…
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Atrial Fibrillation, Supraventricular Tachycardia
- Trial name
- RAPTURE (NCT00787800)
- Testing
- Dual Chamber ICD, Single Chamber ICD
- Where
- 4 sites in United States, Israel
- Volunteers
- 100 people
- Sponsor
- Mayo Clinic
Implantable Cardioverter-Defibrillators
Defibrillation Testing During Implantable Cardioverter Defibrillator (ICD) Replacement
This study will evaluate safety and clinical outcomes of a systematic defibrillation threshold testing in patient with indication for defibrillator replacement.
- Trial name
- T-DEF (NCT04206371)
- Testing
- Defibrillator threshold testing
- Where
- 7 sites in France
- Volunteers
- 143 people
- Sponsor
- CMC Ambroise Paré
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
Cardiomyopathies
Implantable Cardioverter-Defibrillator Use in the VA System
Despite being a proven life-saving intervention in appropriately selected individuals, multiple studies continue to demonstrate low implantation of defibrillators in potential candidates.
- Trial name
- NCT01217827
- Testing
- Clinical Reminder
- Where
- 2 sites in United States
- Volunteers
- 89 people
- Sponsor
- Stanford University
Heart Failure, Obesity
Safety of Body Composition Analysis in Heart Failure Patients With Implantable Cardioverter Defibrillators (ICDs)
The purpose of this study is to define the safety of using bioimpedance for analysis of body composition in heart failure patients with ICD devices.
- Trial name
- NCT01568606
- Testing
- Body Composition Analysis InBody Scale
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of California, Los Angeles
Pediatrics, Defibrillators, Implantable
Precise Measurement of Pediatric Defibrillation Thresholds
Patients who receive an implantable cardioverter-defibrillator (ICD) usually undergo testing at the end of the ICD procedure to measure the amount of energy able to successfully defibrillate the heart (defibrillation threshold…
- Trial name
- NCT01043562
- Testing
- Defibrillator threshold testing, Observation of post-shock intrinsic cardiac rhythm
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Boston Children's Hospital
Cardiomyopathy
Multicenter Automatic Defibrillator Implantation Trial - Chemotherapy-Induced Cardiomyopathy
The purpose of this trial or study is to determine if cardiac resynchronization therapy (CRT) can be a benefit to people who have impaired heart function due to past treatment with chemotherapy and/or chest radiation.
- Trial name
- MADIT-CHIC (NCT02164721)
- Testing
- Three-lead CRT-D (Defibrillator)
- Where
- 9 sites in United States
- Volunteers
- 30 people
- Sponsor
- University of Rochester
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
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
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
Cardiac Arrhythmia
SJM MRI Diagnostic Imaging Registry (IDE)
This study is a prospective, non-randomized, multi-center study of subjects implanted with an SJM pacemakers, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices who are clinically…
- Trial name
- NCT02807948
- Testing
- Pacemaker, ICD, or CRT device
- Where
- 58 sites in United States
- Volunteers
- 189 people
- Sponsor
- Abbott Medical Devices
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
Sudden Cardiac Arrest
Educational Videos to Improve Patient Decision Making and Race Disparities in Implantable Cardioverter Defibrillator Use
The investigators will examine whether an educational video increases patient knowledge about heart failure and the risk of sudden cardiac arrest and leads to greater satisfaction with information provided as compared to usual…
- Trial name
- VIVID-01 (NCT00918125)
- Where
- 2 sites in United States
- Volunteers
- 59 people
- Sponsor
- Duke University
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
Heart Failure
OptiVol® Care Pathway
Medtronic, Inc. is sponsoring the OptiVol® Care Pathway Study, a prospective, randomized, multi-center, post-market clinical trial in the United States.
- Trial name
- NCT00847288
- Testing
- Monthly Review Arm, Quarterly Review Arm
- Where
- 108 sites in United States
- Volunteers
- 1,682 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
CareLink® Network Evaluation
The purpose of the study is to demonstrate the value of the Medtronic CareLink® Network in clinical practice in the country specific healthcare setting.
- Trial name
- NCT01023022
- Testing
- Medtronic CareLink® Network
- Where
- 10 sites in Poland
- Volunteers
- 176 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Congestive Heart Failure
Effect of Posture on Left Ventricular (LV) Transvenous Lead Capture Thresholds (EXPECT)
The purpose of this study is to determine whether changes in a patient's position affect LV capture thresholds in a clinically significant way.
- Trial name
- EXPECT (NCT01520714)
- Testing
- Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Baylor Research Institute
Heart Failure, Ventricular Arrythmias
Safety and Efficacy of Automatic Testing Feature in New ICDs and CRT-Ds
This study is a prospective, non-randomized, multi-center clinical trial that will assess the safety and effectiveness of investigational models of the Promote™ RF CRT-D and Current™ RF ICD devices.
- Trial name
- NCT00746356
- Testing
- Testing of the autocapture features of the device
- Where
- 5 sites in United States
- Volunteers
- 128 people
- Sponsor
- Abbott Medical Devices