Clinical trials: Implantable Cardioverter Defibrillators
Cardiomyopathy, Cardiac Arrhythmia
RF Surgical Sponge-Detecting System on the Function of Pacemakers and Implantable Cardioverter Defibrillators
If a surgical sponge is mistakenly left inside a patient's body after a surgical procedure, it can cause a serious infection. To prevent this from happening, a new device has been developed that uses radiofrequency (RF) signals…
- Conditions
- Cardiomyopathy, Cardiac Arrhythmia, Heart Failure, Chronic Thromboembolic Pulmonary Hypertension
- Trial name
- RF (NCT02111980)
- Testing
- RF Assure Scanning
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of California, San Diego
Tachycardia, Ventricular Fibrillation
Safety and Performance Study of the RELIANCE 4-Front Passive Fixation Lead
The objective of this study is to gather data to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONT™ Passive Fixation Defibrillation Leads.
- Conditions
- Tachycardia, Ventricular Fibrillation, Ventricular Flutter
- Trial name
- NCT01856491
- Testing
- RELIANCE 4-FRONT™ Passive Fixation lead implantation
- Where
- 11 sites in Germany, Israel and 1 more
- Volunteers
- 167 people
- Sponsor
- Boston Scientific Corporation
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
Magnetic Resonance Imaging
ENABLE MRI (Magnetic Resonance Imaging)
The objective of this study is to collect data to confirm the safety and effectiveness of the Image Ready™ MR (Magnetic Resonance) Conditional Defibrillation System when used in the 1.5T (Tesla) MRI environment under the labeled…
- Trial name
- ENABLE-MRI (NCT02652481)
- Testing
- ImageReady MR Conditional Defibrillation System
- Where
- 57 sites in United States, Belgium and 7 more
- Volunteers
- 500 people
- Sponsor
- Boston Scientific Corporation
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
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
Heart Failure With Reduced Ejection Fraction, Heart Failure With Mid Range Ejection Fraction
Ertugliflozin to Reduce Arrhythmic Burden in ICD/CRT patientS (ERASe-Trial) - a Phase III Study
The recent study is planned to investigate the impact of Ertugliflozin on total burden of ventricular arrhythmias. Further objectives will be number of therapeutic interventions of implanted devices, atrial fibrillation, heart…
- Conditions
- Heart Failure With Reduced Ejection Fraction, Heart Failure With Mid Range Ejection Fraction, Implantable Cardioverter-Defibrillators, Cardiac Resynchronization Therapy
- Trial name
- ERASE (NCT04600921)
- Testing
- Ertugliflozin 5 mg
- Where
- 8 sites in Austria
- Volunteers
- 55 people
- Sponsor
- Medical University of Graz
Diabetic Retinopathy, Macular Degeneration
Advancing Understanding of Transportation Options
This Stage II randomized, controlled, longitudinal trial seeks to assess the acceptability, feasibility, and effects of a driving decision aid use among geriatric patients and providers.
- Conditions
- Diabetic Retinopathy, Macular Degeneration, Glaucoma, Retinitis Pigmentosa
- Trial name
- AUTO (NCT04141891)
- Testing
- Driving Decision Aid, Older Drivers Website
- Where
- 3 sites in United States
- Volunteers
- 529 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
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
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
Tachyarrhythmia
Full Automaticity and Remote Follow-up
With the expansion of Sudden Cardiac Death (SCD) primary prevention indications, the number of Implantable Cardioverter Defibrillators (ICD) implants has increased significantly in the recent years.
- Trial name
- NCT01526629
- Where
- France
- Volunteers
- 354 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Ventricular Tachycardia
Pilot Study of Catheter Ablation for Ventricular Tachycardia in Patients With an Implantable Cardioverter Defibrillator
The purpose of this pilot trial is to determine the feasibility of a large, multi-center randomized clinical trial aimed to test whether a treatment strategy of percutaneous catheter ablation of ventricular tachycardia (VT) is…
- Trial name
- CALYPSO (NCT01576042)
- Testing
- amiodarone, sotalol, Biosense Webster's NAVI-STAR Thermo-Cool
- Where
- 5 sites in United States
- Volunteers
- 27 people
- Sponsor
- Duke University
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
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.
Cardiomyopathy
Comparison of VF Induction Techniques During Medtronic ICD Implant (VF) (ICD)
As the indications for Implantable Cardioverter Defibrillator implantation expand, minimizing implant time is critical. Also, patients receiving biventricular ICDs are sometimes more unstable and minimization of sedation time is…
- Trial name
- VF (NCT02027883)
- Testing
- Nominal T shock setting, Educated T shock setting
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- James Merrill
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.
Tachycardia, Ventricular, Ventricular Fibrillation
ADVANCE-D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy
The purpose of this study is to estimate and quantify the difference in efficacy of two sequences of ATP therapies (burst 15 pulses, 88% versus burst 8 pulses, 88%) during an episode of spontaneous rhythms classified as fast…
- Trial name
- ADVANCE_D (NCT00147277)
- Testing
- Implantable Cardiac Defibrillator
- Where
- Italy
- Volunteers
- 925 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure, Congestive
PARTNERS HF: Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure
The purpose of this study is to determine the value of diagnostic data obtained from Medtronic implantable cardioverter defibrillators (ICDs) with cardiac resynchronization therapy (CRT) to evaluate cardiovascular and heart…
- Trial name
- NCT00279955
- Testing
- Cardiac Resynchronization Therapy Device
- Where
- 93 sites in United States
- Volunteers
- 1,024 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