Clinical trials: ICD Patients, active
Heart Failure and Reduced Ejection Fraction
Developing 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
- NCT07084142
- Testing
- Online, patient-facing decision-making aid (app) with personalized risk information., Implantable Cardioverter Defibrillator (ICD), Online, patient-facing decision-making app without personalized risk information.
- Where
- 2 sites in United States
- Volunteers
- 600 people
- Sponsor
- Stanford University
Quality of Life (QOL) and Impact of Stress
Quality of Life and the Influence of Stress on the Postoperative Course of Patients After Device Implantation
The project "Investigating Quality of Life and the Influence of Stress on the Postoperative Course of Patients After Device Implantation" aims to investigate the relationship between stress and the postoperative healing process…
- Trial name
- NCT07343466
- Testing
- Survey using a questionnaire.
- Where
- Germany
- Volunteers
- 300 people
- Sponsor
- University Hospital, Essen
Sudden Cardiac Death
Dilated Cardiomyopathy - Unknown Therapeutic Risk Reduction by Contempary Medication and Implantable Cardioverter-Defibrillators (DUTCH-ICD)
Research questions: The value of primary prevention implantable cardioverter-defibrillator implantation (ICD) therapy in patients with non-ischemic cardiomyopathy (NICM) is under debate.
- Trial name
- DUTCH-ICD (NCT07415642)
- Testing
- ICD implantation
- Where
- 2 sites in Netherlands
- Volunteers
- 720 people
- Sponsor
- University Medical Center Groningen
Heart Failure, Implantable Cardioverter Defibrillator (ICD)
Comparison of the Effects of Different Upper Extremity Aerobic Exercise Training Protocols on Arm Functional Capacity in Patients With Heart Failure With Cardiac Implantable Electronic Devices
1. To determine the most suitable exercise protocol for upper extremity aerobic exercise training, a widely used type of aerobic exercise to improve reduced upper extremity functional capacity in individuals with CIED and HF. 2.
- Conditions
- Heart Failure, Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy Devices
- Trial name
- NCT07592494
- Testing
- High-Intensity Interval Upper Extremity Aerobic Exercise Training, Moderate Intensity Continuous Upper Extremity Aerobic Exercise Training, Lower Extremity Aerobic Exercise Training
- Where
- Turkey (Türkiye)
- Volunteers
- 36 people
- Sponsor
- Erol Olcok Corum Training and Research Hospital
HCM - Hypertrophic Cardiomyopathy, S-ICD System (implantable Defibrillator)
An Observational Study of Subcutaneous Implantable Cardioverter Defibrillator in Patients with Hypertrophic Cardiomyopathy At High Risk of Sudden Cardiac Death
1. To observe the failure rate of S-ICD screening in HCM patients at high risk of SCD. 2. To observe the incidence of IAS in HCM patients with S-ICD implantation and explore the related factors of IAS.
- Trial name
- NCT06604169
- Where
- China
- Volunteers
- 589 people
- Sponsor
- China National Center for Cardiovascular Diseases
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
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
Myocarditis, Ventricular Arrythmia
Role of Endomyocardial Biopsy and Aetiology-based Treatment in Patients With Inflammatory Heart Disease in Arrhythmic and Non-arrhythmic Clinical Presentations: an Integrated Approach for the Optimal Diagnostic and Therapeutic Management
Myocarditis is a complex inflammatory disease, usually occurring secondary to viral infections, autoimmune processes or toxic agents.
- Conditions
- Myocarditis, Ventricular Arrythmia, Inflammatory Cardiomyopathy, Genetic Predisposition
- Trial name
- MYOCAR (NCT04521790)
- Testing
- support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation
- Where
- Italy
- Volunteers
- 1,000 people
- Sponsor
- Scientific Institute San Raffaele
Heart Failure, Ischemic Cardiomyopathy
18F-mFBG Imaging for Myocardial Sympathetic Innervation
This is a Phase 2 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for quantification of myocardial sympathetic innervation.
- Conditions
- Heart Failure, Ischemic Cardiomyopathy, ICD Patients
- Trial name
- NCT06965621
- Testing
- 18F-metaFluorobenzylguanidine, Rubidium-82
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)
Implantable Cardioverter Defibrillator (ICD)
To Test an e-Health Educational Intervention Patients With an ICD
Role of the implantable cardioverter defibrillator (ICD) is to monitor heart rate and discharge a small electrical discharge or shock if the heart rate becomes life threatening.
- Trial name
- CHOICE-ICD (NCT06667505)
- Testing
- Choice-ICD
- Where
- 2 sites in United Kingdom
- Volunteers
- 256 people
- Sponsor
- University of Ulster
Heart Failure
Primary Preventive Ventricular Tachycardia Ablation In High-Risk Patients Who Receive A Prophylactic Implantable Cardioverter Defibrillator
This prospective, multicenter, open-label, randomized-controlled trial compares two treatment strategies in high-risk ischemic cardiomyopathy (ICM) patients referred for primary ICD implantation.
- Trial name
- PREVENT-VT (NCT06543173)
- Testing
- Prophylactic Catheter-based VT Ablation
- Where
- 5 sites in Denmark, France and 1 more
- Volunteers
- 62 people
- Sponsor
- University of Rochester
HCM - Hypertrophic Cardiomyopathy, Sudden Cardiac Death
Left Bundle Branch Pacing in Patients With Hypertrophic Cardiomyopathy After Myectomy
Pilot interventional randomized clinical trial to study the efficacy of left bundle branch pacing in patients with hypertrophic cardiomyopathy after myectomy for the prevention of progression of heart failure, prevent the…
- Conditions
- HCM - Hypertrophic Cardiomyopathy, Sudden Cardiac Death, Left Bundle Branch Pacing, ICD
- Trial name
- LEFTpaceHCM (NCT07372196)
- Testing
- ICD with left bundle branch area pacing (LBBAP), dual-chamber ICD
- Where
- Russia
- Volunteers
- 30 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
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
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
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 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