Clinical trials: Defibrillator
Ventricular Arrhythmias
Clinical Investigation of the Medtronic EnTrust™ Implantable Cardioverter Defibrillator (ICD), Model D153ATG
People who have a dangerously fast heart beat, or whose heart is at risk of stopping beating, may be in need of an electronic device called an implantable cardioverter defibrillator (ICD).
- Trial name
- NCT00273195
- Testing
- Implantable Cardioverter Defibrillator
- Where
- 41 sites in United States, Austria and 5 more
- Volunteers
- 500 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Ventricular Tachycardia, Ventricular Fibrillation
OPERA: French Observational Study on Patients Implanted With a Guidant PRIZM or Vitality Defibrillator
This study evaluates the date of the first appropriate and/or inappropriate therapy in patients implanted with a Guidant PRIZM or VITALITY defibrillator and is evaluating eventual predictive risk factors for…
- Trial name
- NCT00180375
- Testing
- Prizm, Vitality, Renewal
- Where
- 33 sites in France
- Volunteers
- 636 people
- Sponsor
- Boston Scientific Corporation
Implantable Cardiac Device. Patients With a NMR Indication
Patients With Implantable Cardiac Devices Requiring a Nuclear Magnetic Resonance
The general objective of this registry is to study the number of patients carrying an implantable cardiac device that have an indication for an imaging diagnosis based on nuclear magnetic resonance.
- Trial name
- RESONANCE (NCT04330898)
- Testing
- Biotronik peacemakers, implantable cardioverter-defibrillators and cardiac resynchronizers
- Where
- 20 sites in Spain
- Volunteers
- 1,248 people
- Sponsor
- Trialance SCCL
Tachyarrhythmia
Study to Verify Proper Detection of Supraventricular Tachyarrhythmia With Single-Lead Dual-Chamber Implantable Cardioverter-Defibrillators (ADRIA)
A unique single-lead dual-chamber implantable cardioverter-defibrillator (ICD) system (produced by Biotronik, Germany) features a conventional electrode in the ventricle (anchored in the ventricular apex) and a floating electrode…
- Trial name
- NCT00324662
- Testing
- Implantable cardioverter-defibrillator
- Where
- 10 sites in Germany, Switzerland
- Volunteers
- 260 people
- Sponsor
- Biotronik SE & Co. KG
Ventricular Tachycardia, Ventricular Fibrillation
First Arrhythmia Collection of Transvenous and Simultaneous Subcutaneous Implantable Defibrillator Data
The purpose of this clinical study is to collect simultaneous, multiple view cardiac signals representing both transvenous ICDs (T-ICD) and sensing vectors from the subcutaneous implantable defibrillator system (S-ICD).
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Atrial Fibrillation
- Trial name
- FACTS (NCT01161589)
- Where
- 4 sites in United States, Netherlands
- Volunteers
- 142 people
- Sponsor
- Boston Scientific Corporation
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
Inappropriate Shocks From Implanted Defibrillator, ICD Replacement or Upgrade
Observational Study on Inappropriate Therapies
The purpose of the study is to assess the incidence of inappropriate shocks at 2 years, in a population of patients undergoing a generator replacement (VR/DR/CRT) or upgrade from a previously implanted ICD (VR/DR)
- Trial name
- OSIRIS (NCT04118803)
- Testing
- ICD replacement or upgrade
- Where
- 58 sites in United States, Austria and 9 more
- Volunteers
- 881 people
- Sponsor
- MicroPort CRM
Ventricular Tachycardia
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Sphere VT is a prospective, multi-center, single-arm, unblinded pivotal clinical study. Adult subjects with recurrent, sustained, monomorphic ventricular tachycardia (MMVT) due to prior myocardial infarction (MI) will be enrolled…
- Trial name
- NCT07585968
- Testing
- Sphere-9 Catheter with the Affera Mapping and Ablation System
- Where
- 7 sites in United States
- Volunteers
- 260 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
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
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
Arrhythmia, Sinus Node Disease
PANORAMA Observational Study
To construct a computerized database of national profiles and epidemiological data on patients wearing Medtronic implantable pacemakers and cardioverter defibrillators (both with or without cardiac resynchronization therapy)…
- Conditions
- Arrhythmia, Sinus Node Disease, Heart Failure, Heart Block
- Trial name
- NCT00382525
- Testing
- Cardiac Rhythm Management device
- Where
- 27 sites in Belgium, India and 4 more
- Volunteers
- 8,586 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Ventricular Fibrillation
INSURE: INcidence Free SUrvival Before and After Implantable Cardioverter Defibrillator (ICD) Replacement
The INSURE trial is a multi-center, prospective trial to collect information about adequate ICD therapies in ICD patients before and after their first elective ICD replacement.
- Trial name
- NCT00180440
- Testing
- ICD
- Where
- Germany
- Volunteers
- 528 people
- Sponsor
- Guidant 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
Heart Failure
Monitoring of Hemodynamics in Heart Failure Patients by Intracardiac Impedance Measurement
Heart Failure (HF) is one of the most frequent diagnoses upon hospitalization and is a major cause of death. Cardiac resynchronization therapy (CRT) using an implantable device for synchronous bi-ventricular stimulation leads to…
- Trial name
- BIODetectHFII (NCT01711281)
- Testing
- Intracardiac Impedance Measurement Algorithm (integrated in CRT-D device)
- Where
- 22 sites in Denmark, Germany and 3 more
- Volunteers
- 68 people
- Sponsor
- Biotronik SE & Co. KG
Need for MRI Imaging With Pacemaker or Implantable Cardioverter Defibrillator Implanted
Registry Study of Clinical Application of MRI Compatible CIED
The purpose of this study is to clear the Safety and Necessity of the Magnetic Resonance Imaging (MRI) in the Presence of CIEDs(Cardiovascular Implantable Electronic Devices).
- Trial name
- NCT02380300
- Volunteers
- 2,067 people
- Sponsor
- Biotronik (Beijing) Medical Device Ltd.
Tachycardia
INTRINSIC RV - Inhibition of Unnecessary RV Pacing With AV Search Hysteresis in ICDs
INTRINSIC RV is a two-armed randomized trial that will compare the effects of innovative dual-chamber pacing with AV Search Hysteresis to standard VVI among ICD patients.
- Trial name
- NCT00148967
- Testing
- Implantable Cardioverter Defibrillator
- Volunteers
- 1,535 people
- Sponsor
- Boston Scientific Corporation
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
Congestive Heart Failure
Evaluation of a Diagnostic Feature in a Cardiac Resynchronization Therapy (CRT) Device
The purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, which has been implemented in a cardiac resynchronization therapy (CRT) device.
- Trial name
- CLEPSYDRA (NCT00957541)
- Testing
- Paradym CRT + Physiological Diagnosis (PhD)
- Where
- United States
- Volunteers
- 520 people
- Sponsor
- ELA Medical, Inc.