Clinical trials: Implantable Cardioverter Defibrillators
Arrhythmia
Establishing a Standard for Peri-operative Implantable Cardioverter Defibrillator (ICD) Patient Education
An implantable cardioverter defibrillator (ICD) administers a shock to terminate potentially life-threatening cardiac arrhythmias. The device saves lives, but presents psychological challenges for patients.
- Trial name
- NCT00845234
- Testing
- Intervention
- Where
- 3 sites in United States
- Volunteers
- 62 people
- Sponsor
- East Carolina University
Atrial Fibrillation, Arrythmia
Arrythmia Burden in Cardiac Contractility Modulation (CCM)
The Impulse Dynamics Optimizer Device is a Food and Drug Administration (FDA) approved; commercially available device indicated for patients with heart failure with reduced ejection fraction (HFrEF).
- Trial name
- ABC (NCT05704426)
- Testing
- Impulse Dynamics Optimizer Device
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Hackensack Meridian Health
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
Atrial Fibrillation, Stroke
Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation
This study aims to determine if treatment with apixaban, compared with aspirin, will reduce the risk of ischemic stroke and systemic embolism in patients with device-detected sub-clinical atrial fibrillation and additional risk…
- Trial name
- ARTESiA (NCT01938248)
- Testing
- Apixaban, aspirin
- Where
- 130 sites in United States, Belgium and 11 more
- Volunteers
- 4,012 people
- Sponsor
- Population Health Research Institute
Coronary Artery Disease
ST Monitoring to Detect Acute Coronary Syndrome Events in Implantable Cardioverter Defibrillator Patients
This is a prospective, non-randomized, multicenter, pivotal Investigational Device Exemption (IDE) study. The intent of this study is to demonstrate the safety and effectiveness of the ST Monitoring Feature in St Jude Medical ICD…
- Trial name
- AnalyzeST (NCT01424722)
- Testing
- Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices
- Where
- 97 sites in United States
- Volunteers
- 2,258 people
- Sponsor
- Abbott Medical Devices
Dilated Cardiomyopathy, Primary Prevention of Sudden Cardiac Death
Electrophysiologic and Morphologic Assessment of the Substrate to Guide Implantation of Defibrillators in Dilated Cardiomyopathy
With the present study the investigators intend to identify the morphologic and electrophysiologic substrate markers of increased arrhythmic risk in patients with dilated cardiomyopathy undergoing implantation of a defibrillator…
- Conditions
- Dilated Cardiomyopathy, Primary Prevention of Sudden Cardiac Death, Implantable Cardioverter Defibrillator
- Trial name
- EMOSIDD (NCT01378572)
- Where
- 3 sites in United States, Italy
- Volunteers
- 200 people
- Sponsor
- Catholic University of the Sacred Heart
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, Systolic
Paced Heart Rate Acceleration for Cardiac Conditioning
A clinical trial of exercise-similar heart rate acceleration delivered via cardiac pacing vs. sham intervention in subjects at rest will be performed.
- Trial name
- HeartExcel (NCT06332391)
- Testing
- Exercise-similar cardiac pacing
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Denice Hodgson-Zingman, MD
Cardiovascular Diseases, Arrhythmias, Cardiac
Multicenter Evaluation of Patients Using LATITUDE Monitoring System
The Multitude is a registry of patients who receive commercially available CIEDs that remotely communicate through the LATITUDE monitoring system and transfer data to a central database.
- Conditions
- Cardiovascular Diseases, Arrhythmias, Cardiac, Heart Failure, Sudden Cardiac Death
- Trial name
- Multitude (NCT06311149)
- Where
- 3 sites in Italy
- Volunteers
- 20,000 people
- Sponsor
- University Hospital of Ferrara
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
Implantable Cardioverter-defibrillators (ICDs)
Syngery-Evaluating the Impact of Decision Aid
The aim of this study is to determine whether it is better to give patients an implantable cardioverter-defibrillators (ICDs) decision aid before they have their first consultation with an implanting cardiac electrophysiologist…
- Trial name
- NCT03832868
- Testing
- Pre-visit timing of receipt of the ICDs implantation decision aid, Post-visit timing of receipt of the ICDs implantation decision aid
- Where
- 3 sites in United States
- Volunteers
- 25 people
- Sponsor
- Emory University
Patients With an Implanted S-ICD Who Continue to Exercise Regularly
Safety of Sports for Patients With a Subcutaneous Implantable Cardioverter Defibrillator
A multicenter observational study designed specifically to collect data on the safety of sport activities in patients with implanted S-ICD systems.
- Trial name
- SPORT-SICD (NCT05754138)
- Testing
- Sport SICD
- Where
- Israel
- Volunteers
- 500 people
- Sponsor
- Eli Sprecher, MD
Chronic Heart Failure
Interactive Patient's Assistant - LUCY
Patients with chronic heart failure (CHF) and reduced left ventricle ejection fraction benefit from cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillator (ICD).
- Trial name
- NCT03474315
- Testing
- Multivariate assessment
- Where
- Poland
- Volunteers
- 600 people
- Sponsor
- Medical University of Warsaw
Cardiac Arrhythmia
Virtual E-health System for Implantable Cardioverter Defibrillators
This is a Canadian multicenter randomized controlled trial to assess remote patient management. Patients will be randomized to remote patient management with VIRTUES versus usual care, and will be stratified by RemoteView vs no…
- Trial name
- VIRTUES ICD (NCT03405740)
- Testing
- Remote Patient Management, Standard of Care
- Where
- 12 sites in Canada
- Volunteers
- 1,115 people
- Sponsor
- Ratika Parkash
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
Congestive Heart Failure, Cardiac Resynchronization Therapy
Improvement in Clinical Outcomes in Heart Failure Patients With ICDs That Practice Meditation
This is a trial to examine the effects of meditation on the incidence of ventricular arrhythmias and the psychological profiles in patients with implanted cardiac defibrillators. We wish to test the following hypotheses: 1.
- Trial name
- NCT00611260
- Testing
- Vipassana Meditation practice and instruction, Standard Medical Care
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- University of California, Davis
Anxiety, Depression
REmote Web Assisted Care for Heart Failure Patients With Implantable Cardioverter Defibrillators
Aim and Background: Although implantable cardioverter defibrillators (ICD) save lives, many ICD-patients experience psychosocial complications such as anxiety disorders, depression and reduced quality of life after…
- Conditions
- Anxiety, Depression, Quality of Life
- Trial name
- REACH-ICD (NCT01589913)
- Testing
- ICD-Forum
- Where
- 7 sites in Germany
- Volunteers
- 118 people
- Sponsor
- Wuerzburg University Hospital
Right Ventricular Dysfunction
Right Ventricular Function Changes After CIED Implantation: The RIGHT-CIED Study
This study aims to understand how the right side of the heart changes in people who receive an implantable cardiac electronic device (CIED), such as a pacemaker, ICD, or CRT device.
- Trial name
- RIGHT-CIED (NCT07272395)
- Testing
- Multimodal Right Ventricular Evaluation
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people
- Sponsor
- Istanbul University - Cerrahpasa
Ventricular Arrythmias
Home-Monitoring in Implantable Cardioverter Defibrillator (ICD) Patients
The purpose of this study is to investigate the cost-effectiveness and effectiveness of remote-monitoring compared to standard care in patients with implantable cardioverter defibrillator.
- Trial name
- Monitor-ICD (NCT00787683)
- Testing
- Home-monitoring provided by LUMAX ICD device and CardioMessenger II
- Where
- 13 sites in Germany
- Volunteers
- 416 people
- Sponsor
- F. Mueller-Riemenschneider