Clinical trials: ICD
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
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
Ventricular Fibrillation
Acute Feasibility Investigation of a New S-ICD Electrode
This is an early-stage feasibility study. This study seeks to characterize the performance of the new electrode shock configuration with the S-ICD
- Trial name
- ASE (NCT03802110)
- Testing
- commercially released subcutaneous implantable cardioverter defibrillator (S-ICD) and the Investigational S-ICD Adapter.
- Where
- 4 sites in Netherlands
- Volunteers
- 42 people
- Sponsor
- Boston Scientific Corporation
First Degree AV Block
Restoration of Atrioventricular Synchrony Trial
The objective of the trial is to observe the effects of restoring atrioventricular (AV) synchrony in subjects with prolonged PR intervals.
- Trial name
- RESTORE-AV (NCT01275833)
- Testing
- Cardiac resynchronization therapy-defibrillator
- Volunteers
- 2 people
- Sponsor
- Boston Scientific Corporation
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
Ventricular Arrhythmia
Evaluating Ventricular Arrhythmia in Subjects With Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy-Defibrillator
The primary objective of this study is to evaluate the effect of eleclazine (GS-6615) compared to placebo on the overall occurrence of appropriate implantable cardioverter-defibrillator (ICD) interventions (antitachycardia pacing…
- Trial name
- TEMPO (NCT02104583)
- Testing
- Eleclazine
- Where
- 84 sites in United States, Canada and 7 more
- Volunteers
- 313 people
- Sponsor
- Gilead Sciences
Heart Disease
Managed Ventricular Pacing ("MVP") Trial
The purpose of the study is to compare two device settings (sets of instructions) used by the ICD. The Implantable Cardiac Defibrillator ("ICD") can be set to use one wire (top or bottom of the heart) or two wires (top and…
- Trial name
- MVP (NCT00281099)
- Testing
- ICD (Implantable Cardioverter Defibrillator)
- Where
- 73 sites in United States, Austria and 10 more
- Volunteers
- 1,031 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Primary Prevention of Sudden Cardiac Arrest, Secondary Prevention of Sudden Cardiac Arrest
Longitudinal Surveillance Study of the 4-SITE Lead/Header System
Post-approval studies of implanted leads provide an opportunity to observe and assess patient outcomes and technology performance in a real-world setting.
- Trial name
- LSS of 4-SITE (NCT01596595)
- Where
- 111 sites in United States, Australia and 1 more
- Volunteers
- 1,820 people
- Sponsor
- Boston Scientific Corporation
Implantable Cardioverter-Defibrillator With Magnetic Resonance Imaging
ProMRI Study of the Iforia ICD System (Phase C)
The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI ICD System when used under specific MRI conditions.
- Trial name
- NCT02096692
- Testing
- Patients with a ProMRI ICD System, Magnetic Resonance Imaging (MRI) scan
- Where
- 39 sites in United States
- Volunteers
- 154 people
- Sponsor
- Biotronik, Inc.
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
Heart Failure
Safety and Efficacy Study of the QuickFlex Micro Model 1258T Left Heart Pacing Lead
This is a prospective, multi-center non-randomized clinical study to evaluate the safety and efficacy of the QuickFlex Micro Model 1258T left ventricular lead in a heart failure patient population.
- Trial name
- NCT00763698
- Testing
- QuickFlex Micro Model 1258T Left Heart Lead
- Where
- 13 sites in United States
- Volunteers
- 86 people
- Sponsor
- Abbott Medical Devices
Arrhythmia
Observation of ImageReady™ MR Conditional Defibrillation System in China
To observe the safety and effectiveness of ImageReady™ MR conditional defibrillation system in a Chinese population.
- Trial name
- NCT03451721
- Testing
- ImageReady™ MR Conditional Defibrillation System
- Where
- China
- Volunteers
- 20 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 Failure
REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE)
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes.
- Trial name
- NCT00271154
- Testing
- Cardiac Resynchronization Therapy (CRT) Device or Implantable Cardioverter Defibrillator (ICD) with CRT
- Where
- 65 sites in United States, Austria and 13 more
- Volunteers
- 684 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiac Implantable Electronic Device Infection
TYRX™ Envelope for Prevention of Infection Following Replacement With a CRT or ICD
The purpose of this study is to compare the incidence of cardiac implantable electronic device (CIED) infection and CIED mechanical complication after CIED replacement with a high-power cardiac implantable electronic device…
- Trial name
- Centurion (NCT01043705)
- Where
- 52 sites in United States
- Volunteers
- 1,262 people
- Sponsor
- TYRX, Inc.
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
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
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
Implantable Defibrillator User
Plexa ICD Lead Registry
The purpose of this registry is to confirm the long-term safety and reliability of BIOTRONIK's Plexa ICD lead.
- Trial name
- NCT03103503
- Where
- 28 sites in United States
- Volunteers
- 901 people
- Sponsor
- Biotronik, Inc.