Clinical trials: ICD, open to volunteers
Arrhythmia, Bradycardia
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
The main purpose of the Product Performance Report (formerly referred to as System Longevity Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm products by analyzing product survival…
- Conditions
- Arrhythmia, Bradycardia, Heart Failure, Sinus Tachycardia
- Trial name
- PPR (NCT00271180)
- Testing
- Device
- Where
- 333 sites in United States, Australia and 33 more
- Volunteers
- 20,000 people
- Sponsor
- Medtronic
Pacemaker, ICD
Monaldi Hospital Rhythm Registry
The study is a prospective registry. Consecutive patients with indications of implant / replacement or upgrade of pacemaker (PM), implantable cardioverter defibrillator (ICD), Implanted loop recorder (ILR) will be enrolled.
- Conditions
- Pacemaker, ICD, Implanted Loop Recorder
- Trial name
- NCT05072119
- Testing
- Device implantation
- Where
- Italy
- Volunteers
- 5,000 people
- Sponsor
- University of Campania Luigi Vanvitelli
Implantable Cardioverter Defibrillator (ICD)
Patient-Reported Quality of Life in Patients With an Implantable-Cardioverter Defibrillator - A Longitudinal Observational Study
Patients at risk for life-threatening arrhythmias are eligible for the implantation of an implantable cardioverter-defibrillator (ICD), which has repeatedly shown improved survival.
- Trial name
- QoL-ICD II (NCT06654284)
- Testing
- quality of life questionnaires
- Where
- Belgium
- Volunteers
- 400 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Sudden Cardiac Death, Myocardial Infarction
Prevention Of Sudden Cardiac Death After Myocardial Infarction by Defibrillator Implantation
Patients who have survived a myocardial infarction (MI) are at increased risk for sudden cardiac death (SCD) caused by ventricular tachycardia and ventricular fibrillation.
- Trial name
- PROFID EHRA (NCT05665608)
- Testing
- Implantable cardioverter-defibrillator (ICD), Optimal Medical Therapy (OMT)
- Where
- 86 sites in Austria, Belgium and 11 more
- Volunteers
- 3,595 people
- Sponsor
- Charite University, Berlin, Germany
Device:MRI
Magnetic Resonance Imaging (MRI) in Patients With Pacemakers and Implanted Cardioverter Defibrillators
Ferromagnetic Implants such as permanent pacemakers (PPM's) and Implantable Cardioverter Defibrillators (ICD's) have traditionally been accepted as contraindications to Magnetic Resonance Imaging (MRI) due to safety concerns.
- Trial name
- NCT02888353
- Testing
- Device: MRI
- Where
- United States
- Volunteers
- 4,500 people
- Sponsor
- Johns Hopkins University
Ventricular Tachycardia, Coronary Artery Disease
Coronary Flow During Rapid Heart Rates
The goal of this observational study is to learn about the factors which determine how well ventricular tachycardia (VT) is tolerated. The main questions it aims to answer are: 1.
- Conditions
- Ventricular Tachycardia, Coronary Artery Disease, Heart Failure, Coronary Microvascular Dysfunction
- Trial name
- VT flow (NCT05841199)
- Testing
- Pressure and flow measurement during simulated VT
- Where
- United Kingdom
- Volunteers
- 70 people
- Sponsor
- Imperial College London
Non-ischemic Cardiomyopathy, Dilated Cardiomyopathy (DCM)
Multimodal and Multidisciplinary Approach to Optimize Diagnostic, Prognostic, and Therapeutic Management of Patients with Non-ischemic Cardiomyopathies and Arrhythmogenic-inflammatory Phenotypes: a Multicenter, Observational, Retrospective and Prospective Registry Study.
Non-ischemic cardiomyopathies (NICM) represent a heterogeneous group of pathologies characterized by absence of obstructive disease of the epicardial coronary vessels and distinct structural and functional changes of the…
- Conditions
- Non-ischemic Cardiomyopathy, Dilated Cardiomyopathy (DCM), Hypertrophic Cardiomyopathy (HCM), Restrictive Cardiomyopathy
- Trial name
- AINICM (NCT06607471)
- Testing
- Support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation, Support treatment, cardiac medical treatment, aetiology-specific treatment
- Where
- Italy
- Volunteers
- 15,000 people
- Sponsor
- Scientific Institute San Raffaele
Tricuspid Valve Regurgitation, Pacemaker
Prospective Study of Lead-associated Tricuspid Regurgitation in Patients Undergoing New Transvalvular Lead Insertion
The goal of this clinical trial is to record the incidence of newly developed or worsening tricuspid valve regurgitation (TR) following the implantation of a pacemaker or defibrillator with a transvenous lead.
- Conditions
- Tricuspid Valve Regurgitation, Pacemaker, ICD, Left Bundle Branch Area Pacing
- Trial name
- LITR (NCT07342036)
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Hazem Omran
Syncope, Bradycardia
Registry of Device Implantation
The implantable device therapy for cardiac arrhythmias has been an established therapy, and one of the common standard procedures in cardiac clinical practice.
- Conditions
- Syncope, Bradycardia, Tachycardia, Sudden Cardiac Death
- Trial name
- NCT03360227
- Testing
- implantation of cardiac devices
- Where
- Germany
- Volunteers
- 2,000 people
- Sponsor
- Klinik für Kardiologie, Pneumologie und Angiologie
Heart Failure, Heart Failure NYHA Class II
Heart Failure Management for Patient With CIED Remotely Monitored
This randomized, controlled, open-label, parallel, multicenter clinical study evaluates the efficacy of SmartSignalHF compared with heart failure (HF) remote monitoring (RM) standard of care in implanted patients with heart…
- Conditions
- Heart Failure, Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure With Reduced Ejection Fraction (HFrEF)
- Trial name
- PROACT-HF (NCT07247032)
- Testing
- SmartSignalHF, HF RM standard of care
- Where
- France
- Volunteers
- 1,132 people
- Sponsor
- Implicity
Subcutaneous ICD, Myopotential Interference
Reduction of Myopotential Interference With Smart Pass in S-ICD Patients
This study is enrolling participants who are already implanted with a S-ICD device ( subcutaneous ICD), and are undergoing a routine outpatient clinic follow up appointment to have their S-ICD checked.
- Trial name
- NCT05766943
- Testing
- Smart Pass ON, Smart Pass OFF
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- Medical University of South Carolina
Heart Failure, Congestive, Death, Sudden, Cardiac
Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention
The overall hypothesis of this study is that subtle interactions between structural (substrate) and functional (trigger) abnormalities of the heart, some of which are genetically-determined, can be used to identify patients at…
- Conditions
- Heart Failure, Congestive, Death, Sudden, Cardiac, Arrhythmia, Cardiomyopathies
- Trial name
- PROSe-ICD (NCT00733590)
- Where
- 4 sites in United States
- Volunteers
- 1,500 people
- Sponsor
- Johns Hopkins University
Arrhythmogenic Cardiomyopathy (AC, ARVD/C), Ventricular Tachycardia (VT)
Treatment Registry of Arrhythmias, Complications and Electrocardiograms in Arrhythmogenic CardioMyopathies
TRACE-ACM is a multicenter, retrospective, observational study of patients with arrhythmogenic cardiomyopathy who received an implantable cardioverter-defibrillator (ICD) and had documented ventricular tachyarrhythmias.
- Conditions
- Arrhythmogenic Cardiomyopathy (AC, ARVD/C), Ventricular Tachycardia (VT), Ventricular Fibrillation, ICD
- Trial name
- TRACE-ACM (NCT07688200)
- Volunteers
- 300 people
- Sponsor
- Policlinico Casilino ASL RMB
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
Tetralogy of Fallot, Implantable Defibrillator User
French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator
National french registry of patients with tetralogy of Fallot and implantable cardioverter defibrillator.
- Conditions
- Tetralogy of Fallot, Implantable Defibrillator User, Congenital Heart Disease, Sudden Cardiac Death
- Trial name
- DAI-T4F (NCT03837574)
- Where
- France
- Volunteers
- 150 people
- Sponsor
- Paris Sudden Death Expertise 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 Arrhythmia, Ventricular Tachycardia
IVTCC 2.0: A Prospective Multicenter Ventricular Tachycardia Catheter Ablation Registry
This is a prospective multi-center international registry. The objective of this registry is to collect prospective data on patients undergoing catheter ablation for Ventricular Tachycardia (VT) and Premature Ventricular…
- Conditions
- Ventricular Arrhythmia, Ventricular Tachycardia, Premature Ventricular Contraction (PVC), Cardiomyopathy
- Trial name
- IVTCC (NCT04520347)
- Where
- 41 sites in United States, Canada and 5 more
- Volunteers
- 10,000 people
- Sponsor
- University of California, Los Angeles
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
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
Implantable Cardioverter Defibrillator (ICD)
Observational BELgian Registry of Implanted EV-ICD to Evaluate Parameters and Complications of the New Device in Real World Settings
The goal of this observational study is to follow all patients implanted with extravascular implantable cardioverter-defibrillators (EV-ICDs) in Belgium throughout the lifetime of the devices.
- Trial name
- BELIEVE (NCT07156851)
- Where
- 7 sites in Belgium
- Volunteers
- 100 people
- Sponsor
- AZ Sint-Jan AV