Clinical trials: Implantable Cardioverter Defibrillators
Tachycardia
Reduction of Inappropriate Shocks of Implantable Cardioverter Defibrillators (ICDs) With Enhanced SVT Discriminators
The purpose of this clinical investigation is the continued assessment of the decision accuracy of St. Jude Medical (SJM) ICD with enhanced SVT discriminators in the treatment of subjects with primary and secondary prevention of…
- Trial name
- ReduceIT (NCT01963286)
- Testing
- ICD with enhanced SVT discriminators
- Where
- 23 sites in Estonia, Germany
- Volunteers
- 735 people
- Sponsor
- Abbott Medical Devices
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
Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic Heart Failure (HF) (REDUCEhf)
The purpose of this clinical research study is to evaluate the safety and effectiveness of the investigational implantable hemodynamic monitor (IHM), and of the IHM in combination with an implantable cardioverter defibrillator…
- Trial name
- REDUCEhf (NCT00354159)
- Testing
- Implantable Hemodynamic Monitor (Chronicle® IHM), and IHM in combination with single chamber ICD (Chronicle ICD)
- Where
- 52 sites in United States
- Volunteers
- 442 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Ventricular Tachycardia, Ventricular Fibrillation
DAVID II (Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial II)
The DAVID II Clinical Study evaluates the hypothesis that, in patients needing an ICD but without overt indications for pacing, AAI pacing with maximal concomitant drug therapy will not increase the rate of the combined endpoint…
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Sudden Cardiac Death, Congestive Heart Failure
- Trial name
- DAVIDII (NCT00187187)
- Testing
- Implantable Defibrillator (ICD)
- Volunteers
- 600 people
- Sponsor
- Abbott Medical Devices
Tachycardia, Ventricular, Ventricular Fibrillation
ADVANCE CRT - D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy
To compare the efficacy of RV and BiV ATP for the termination of ventricular arrhythmias in patients who are candidates to a cardiac resynchronisation therapy (CRT) and have a Class I or IIA indication for ICD implantation.
- Trial name
- ADVANCE-CRTD (NCT00147290)
- Testing
- Implantable Cardiac Defibrillator
- Where
- Italy
- Volunteers
- 526 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiac Electrophysiology
Transvenous Lead Removal Post-Market Clinical Study
This prospective, multicenter, post-market clinical study was designed to evaluate the outcomes of lead extraction of cardiovascular implantable electronic devices (CIED) using Cook catheter and lead extraction devices for any…
- Trial name
- NCT03688412
- Testing
- Cook lead extraction devices
- Where
- 9 sites in United States, Germany and 2 more
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- Cook Research Incorporated
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
Cardiac Pacing, Electric Countershock
Follow-up of Patients With Implantable Cardioverter Defibrillators by Home Monitoring (ANVITE)
Patients with implantable cardioverter defibrillators (ICDs) should undergo regular device follow-ups every 3 months, to verify proper ICD function.
- Conditions
- Cardiac Pacing, Electric Countershock, Ventricular Tachyarrhythmia
- Trial name
- ANVITE (NCT00858559)
- Testing
- Implantable cardioverter defibrillator with Home Monitoring function, Standard implantable cardioverter defibrillator
- Where
- Germany
- Volunteers
- 110 people
- Sponsor
- Biotronik SE & Co. KG
Cardiac Resynchronization, Biventricular Pacemakers, Artificial
Assessment of Ventricular Arrhythmia Risk After CRT-D Replacement for Patients With Primary Prevention Indication
Cardiac resynchronization therapy (CRT) has been shown to reduce heart failure (HF), hospitalizations and death in patients with left ventricular ejection fraction (LVEF) <35% and wide QRS.
- Conditions
- Cardiac Resynchronization, Biventricular Pacemakers, Artificial, Cardioverter-Defibrillators, Implantable, Device Replacement
- Trial name
- BioCONTINUE (NCT02323503)
- Testing
- CRT-D device replacement
- Where
- 37 sites in Belgium, France and 6 more
- Volunteers
- 289 people
- Sponsor
- Biotronik SE & Co. KG
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
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
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
Arrhythmia, Quality of Life
Psychosomatic Effects of Implantable Cardioverter Defibrillator With Home Monitoring Function (QUANTUM)
Quality of life (QOL) and psychological well-being of patients with implantable cardioverter-defibrillators (ICDs) are significantly influenced by the experience of shock therapies.
- Trial name
- NCT00325221
- Testing
- HM on, HM Off
- Where
- 7 sites in Austria, Germany and 1 more
- Volunteers
- 148 people
- Sponsor
- Biotronik SE & Co. KG
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
Primary Prevention, Tachycardia, Ventricular
Survival of Patients With Primary Prophylactic ICD Indication
The MADIT-II trial has shown that patients with severely reduced left ventricular ejection fraction (LVEF) post myocardial infarction benefit from the implantable cardioverter-defibrillator (ICD).
- Conditions
- Primary Prevention, Tachycardia, Ventricular, Sudden Cardiac Death
- Trial name
- SPIRIT-ICD (NCT00619593)
- Testing
- Intensified diagnostic and treatment measures following 1st appropriate ICD therapy, Standard follow-up
- Where
- 37 sites in Austria, Czechia and 9 more
- Volunteers
- 504 people
- Sponsor
- Biotronik SE & Co. KG
Bradycardia, Sudden Cardiac Arrest
Feasibility Study of Remote Support for Implantable Pulse Generator (IPG)/Implantable Cardioverter Defibrillator (ICD) Implant
The purpose of this study is to gain real world, live implant experience with the remote implant support system. This system is intended to provide the technical support for device implants from a remote location through…
- Trial name
- NCT01809652
- Testing
- Remote Implant Support Capability
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
The Patient Meets ACC/AHA/ESC Guidelines for Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT-D) Device
Clinical Evaluation Of Remote Monitoring With Direct Alerts To Reduce Time From Event To Clinical Decision
St. Jude Medical developed the Merlin.net™ Patient Care Network (Merlin.net™ PCN) to augment or replace routine scheduled in-clinic visits.
- Trial name
- REACT (NCT01090349)
- Testing
- Implantation of an ICD/CRT-D device, Merlin.NET PCN
- Where
- 2 sites in Germany, United Kingdom
- Volunteers
- 220 people
- Sponsor
- Abbott Medical Devices
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
Tachycardia, Ventricular
SMS: Substrate Modification Study in Patients Getting an Implantable Cardioverter Defibrillator (ICD)
The present standard of care for the management of unstable ventricular tachycardia (VT) in the setting of chronic coronary artery disease is the placement of an implantable cardioverter defibrillator (ICD) after the initial…
- Trial name
- SMS (NCT00170287)
- Testing
- ICD Ablation plus VT-ablation, ICD Therapy
- Where
- 7 sites in Denmark, Germany
- Volunteers
- 116 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
ICD and CRT-D Indicated Patients
The 4-SITE Field Following Study (4-SITE FF)
The purpose of this study is to evaluate and document appropriate clinical performance of the new 4-SITE Header / Lead interface in the TELIGEN 100 HE 4-SITE (VR and DR) implantable cardioverter defibrillator (ICD) PGs (Models…
- Trial name
- 4-SITE FF (NCT00920452)
- Where
- Germany
- Volunteers
- 430 people
- Sponsor
- Guidant Corporation