Clinical trials: ICD, open to volunteers
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
Shared Decision-making
Evaluating a Digital Aid to Improve ICD Decisions
Advanced heart failure, affecting 7 million Americans, has multiple causes and results in greatly increased risk of disability and death.
- Trial name
- NCT07913204
- Testing
- Arm A: Online, patient-facing decision-making aid (app) with personalized risk information., Arm B - Online, patient-facing decision-making app without personalized risk information., Arm C - Usual Care/No Device
- Where
- 2 sites in United States
- Volunteers
- 600 people
- Sponsor
- Stanford University
Mitral Valve Prolapse, Ventricular Arrhythmias and Cardiac Arrest
Mitral Valve Prolapse Arrhythmic Risk
Mitral valve prolapse (MVP) is common with a 2-3 % prevalence in the general association and generally associated with a favorable prognosis.
- Trial name
- MVP-Risk (NCT07830888)
- Testing
- Risk prediction model
- Where
- Norway
- Volunteers
- 500 people
- Sponsor
- Oslo University Hospital
Heart Failure With Reduced Ejection Fraction (HFrEF), Sudden Cardiac Death
Comparative Effectiveness of Carvedilol Versus Metoprolol Succinate in Heart Failure Patients With an Implantable Cardioverter Defibrillator
This prospective, multicenter, open-label, randomized comparative effectiveness trial, titled CARVTOP-ICD, evaluates the impact of carvedilol versus metoprolol succinate in patients with heart failure with reduced ejection…
- Conditions
- Heart Failure With Reduced Ejection Fraction (HFrEF), Sudden Cardiac Death, Ventricular Arrhythmia, Implantable Cardioverter Defibrillator (ICD)
- Trial name
- CARVTOP-ICD (NCT06964464)
- Testing
- Metoprolol Succinate, Carvedilol
- Where
- 13 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- University of Rochester
Ventricular Arrhythmia, Acute Myocardial Infarction (AMI)
Ventricular Arrhythmias in Acute Myocardial Infarction
Ventricular arrhythmias are a serious complication of myocardial infarction. The aim of this study is to provide reliable data on the management and mortality associated with ventricular arrhythmia in the setting of acute…
- Trial name
- ADVERSE-MI (NCT07517523)
- Where
- 8 sites in France
- Volunteers
- 500 people
- Sponsor
- Poitiers University Hospital
Cardiac Pacemaker Malfunction, ICD Malfunction
Perioperative Management Evaluation in Patients With CIED
Background: Recommendations for peri-operative management in patients with implanted cardiac electronic devices (CIED) are often based on older data from case reports and small collectives.
- Conditions
- Cardiac Pacemaker Malfunction, ICD Malfunction, Cardiac Pacemaker Electrical Interference, Anesthesia Complication
- Trial name
- EVINCE (NCT04331249)
- Testing
- surgery or catheter based cardiac procedure (catheter ablation)
- Where
- 2 sites in Germany
- Volunteers
- 500 people
- Sponsor
- Klinikum-Fuerth
Ventricular Arrhythmias and Cardiac Arrest
Using Mirabegron to Control Arrhythmia-1
To evaluate mirabegron's effect on ventricular arrhythmia control. The study will be conducted in ambulatory patients with ventricular tachycardia (VT), organic heart diseases, and an implantable cardioverter-defibrillator (ICD).
- Trial name
- MACH-1 (NCT07566208)
- Testing
- Mirabegron
- Volunteers
- 20 people
- Sponsor
- Cedars-Sinai Medical Center
Heart Failure and Reduced Ejection Fraction
Evaluation of Accelerated Bachmann Bundle Area Pacing in Heart Failure With Reduced ejectIon Fraction Who Have electrocarDioGraphic Evidence of Interatrial Block and Indicated for Implantable Cardioverter Defibrillator
To evaluate the effect of accelerated atrial resynchronization achieved through Bachmann bundle pacing at the time of implantable cardioverter-defibrillator implantation in patients with heart failure with reduced ejection…
- Trial name
- BRIDGE-HF (NCT07547306)
- Testing
- BBAP on, BBAP off, RAAP
- Volunteers
- 120 people
- Sponsor
- Seoul National University Hospital
Ventricular Tachycardia (VT)
Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS)
Sphere-9 VT EFS is a prospective, multi-center, non-randomized, unblinded feasibility study. Adult subjects with recurrent, sustained, scar-related monomorphic ventricular tachycardia will be enrolled and treated with the…
- Trial name
- NCT06703489
- Testing
- Sphere-9 Catheter with the Affera Mapping and Ablation System
- Where
- 6 sites in United States
- Volunteers
- 60 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation, Pacemaker Ddd
Prospective Database for Prediction of Atrial Fibrillation in Pacemaker and ICD Patients
Atrial fibrillation (AF) is associated with a five-fold increased risk of cerebrovascular stroke. While the risk of stroke in patients with known AF can be calculated via AF stroke prediction risk scores, the prediction of AF…
- Conditions
- Atrial Fibrillation, Pacemaker Ddd, ICD
- Trial name
- SAFE-ME (NCT03357926)
- Testing
- 24 hour Holter ECG Monitoring
- Where
- Austria
- Volunteers
- 250 people
- Sponsor
- Medical University of Graz
Cardiac Pacing, Cardiac Pacemaker
BIO|STREAM.CSP Study
The registry is designed to assess outcome, performance and residual safety aspects of BIOTRONIK products which are used in the context of CSP based on long-term data from an unselected, real-life clinical set-up.
- Conditions
- Cardiac Pacing, Cardiac Pacemaker, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy Devices
- Trial name
- NCT07393009
- Testing
- Implantation of the Solia CSP S pacing lead for LBBAP
- Where
- 46 sites in Australia, Austria and 11 more
- Volunteers
- 1,000 people
- Sponsor
- Biotronik SE & Co. KG
Sick Sinus Syndrome, Atrioventricular Block, Second and Third Degree
Evaluating the Safety and Effectiveness of 5G Cloud Follow-up for Cardiovascular Implantable Electronic Devices
Objective: This clinical study employs a prospective, paired, self-controlled, non-inferiority, multicenter research design to assess the safety and efficacy of utilizing 5G cloud follow-up for CIED in parameters monitoring and…
- Conditions
- Sick Sinus Syndrome, Atrioventricular Block, Second and Third Degree, Heart Failure
- Trial name
- CIED-CARE (NCT06652750)
- Testing
- Routine Management, 5G Cloud Follow-up
- Where
- 2 sites in China
- Volunteers
- 688 people
- Sponsor
- The Third People's Hospital of Chengdu
Appropriate and Inappropriate Shock Therapy With ICD, Arrhythmias Detection
Arrhythmias Detection in a Real World Population
The study is a prospective multicenter registry. Consecutive patients with indications of implant / replacement or upgrade of implantable cardioverter defibrillator (ICD) will be enrolled.
- Trial name
- RHYTHM DETECT (NCT02275637)
- Testing
- implantable cardioverter defibrillator
- Where
- 12 sites in Italy
- Volunteers
- 10,000 people
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
Angina Pectoris, Variant, Sudden Cardiac Death
Implantable Cardioverter Defibrillator Versus Optimal Medical Therapy In Patients With Variant Angina Manifesting as Aborted Sudden Cardiac Death
The purpose of this study is to determine whether ICD(Implantable Cardioverter Defibrillator) implantation on the top of optimal medical therapy in patients with variant angina manifesting as aborted sudden cardiac death reduces…
- Trial name
- VARIANT ICD (NCT02845531)
- Testing
- Implantable Cardioverter Defibrillator, Optimal Medical Therapy
- Where
- 26 sites in South Korea
- Volunteers
- 140 people
- Sponsor
- Kee-joon Choi
HFrEF - Heart Failure With Reduced Ejection Fraction, HFmrEF
Coffee Use, Physical Activity and Symptomatic Ventricular Arrhythmias in Patients With Left Ventricular Dysfunction and an ICD
The goal of this observational study is to learn whether caffeine consumption is associated with ventricular arrhythmias and physical activity in adults with heart failure, reduced left ventricular ejection fraction, and an…
- Conditions
- HFrEF - Heart Failure With Reduced Ejection Fraction, HFmrEF, Ventricular Arrhythmia, ICD
- Trial name
- CUPS-ICD (NCT07823998)
- Testing
- Questionnaire
- Where
- Belgium
- Volunteers
- 170 people
- Sponsor
- Jean-Benoît Le Polain de Waroux
Pacemakers, MRI Imaging
The MagnaSafe-2 Registry: Assessing the Risks of Magnetic Resonance Imaging in Three Patient Groups
SUMMARY OF THE CLINICAL PROTOCOL Background: The risks of Magnetic Resonance Imaging (MRI) at 1.5-tesla for patients with a non-MRI-conditional (NMRC) pacemaker have been documented, guidelines for clinical practice have been…
- Conditions
- Pacemakers, MRI Imaging, Implantable Cardioverter Defibrillator (ICD)
- Trial name
- NCT07189728
- Testing
- MRI
- Volunteers
- 1,500 people
- Sponsor
- The Scripps Research Institute
Heart Failure
RCT of Implantable Defibrillators in Patients With Non Ischemic Cardiomyopathy, Scar and Severe Systolic Heart Failure
BRITISH is a UK multicentre trial of patients who have been diagnosed with heart failure due to Non-Ischemic Cardiomyopathy (NICM, or heart failure that is not caused by blocked heart arteries.
- Trial name
- BRITISH (NCT05568069)
- Testing
- Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronisation Therapy Defibrillator (CRTD)
- Where
- 47 sites in United Kingdom
- Volunteers
- 2,504 people
- Sponsor
- University Hospital Southampton NHS Foundation Trust
Ventricular Arrythmia, Ventricular Fibrillation
Parasternal Extravascular ICD System Pivotal Clinical Investigation (ALARION EV) Study
The ALARION EV Study is a prospective, multi-center, single-arm, non-randomized study without concurrent or historical controls.
- Conditions
- Ventricular Arrythmia, Ventricular Fibrillation, Ventricular Tachycardia
- Trial name
- ALARION EV (NCT07324031)
- Testing
- Atala™ lead and EV-ICD Pulse Generator
- Where
- 35 sites in United States, Netherlands
- Volunteers
- 280 people
- Sponsor
- AtaCor Medical, Inc.
Implantable Defibrillator User
Investigation of the Audible ICD Alert Tone
Ability of ICD patients to hear the audible ICD alert is being assessed.
- Trial name
- NCT06388382
- Testing
- Alert tone demonstration
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- Universitätsklinikum Köln
Arrhythmia, Cardiac Implantable Electronic Device
Virtual Reality in Electrophysiological Procedures and Device Implantation: the VR inEP Trial
Each year about 37,000 patients undergo a catheter ablation to treat cardiac arrhythmias or have a cardiac device such as a pacemaker or implantable cardioverter defibrillator implanted in the Netherlands.
- Conditions
- Arrhythmia, Cardiac Implantable Electronic Device, Ablation of Arrhythmias, Electrophysiologic Study
- Trial name
- VR inEP (NCT07105241)
- Testing
- VR therapy, 360 degree education videos
- Volunteers
- 115 people
- Sponsor
- Radboud University Medical Center