Clinical trials: Implantable Cardioverter-defibrillators (ICDs)
Coronary Artery Disease, Arrhythmia
Effect of Supplemental Intake of Omega-3 Polyunsaturated Fatty Acids on the Rate and Complexity of Spontaneously Occurring Ventricular and Supraventricular Arrhythmias in Patients With Implantable Cardioverter Defibrillator (ICD) - A Randomized Clinical Trial
We hypothesize that oral supplementation with omega-3 PUFA will decrease occurrence of arrhythmic events among post-MI, ICD recipients.
- Trial name
- NCT00290056
- Testing
- Eicosapentanoic acid (EPA) and Docosahexanoic acid (DHA).
- Where
- 2 sites in Israel
- Volunteers
- 105 people
- Sponsor
- Sheba Medical Center
Sudden Cardiac Death, Cardiac Arrest
Experience From the Italian S-ICD Registry
The purpose of this registry is to collect data on implant parameters, early, mid and long-term clinical effectiveness of Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) therapies in order to better understand how to…
- Conditions
- Sudden Cardiac Death, Cardiac Arrest, Ventricular Arrythmia, Implantable Cardiac Defibrillator
- Trial name
- ELISIR (NCT04373876)
- Testing
- Subcutaneous Implantable Cardioverter Defibrillator
- Where
- 18 sites in France, Germany and 2 more
- Volunteers
- 500 people
- Sponsor
- Luigi Sacco University Hospital
Non-ischemic Cardiomyopathy, Heart Failure
LBBP as Initial Therapy in Patients With Non-ischemic Heart Failure and LBBB
The present study will recruit 50 symptomatic non-ischemic cardiomyopathy (NICM) patients with left ventricular ejection fraction (LVEF) below 35% and complete left bundle branch block (CLBBB), who have not received complete…
- Conditions
- Non-ischemic Cardiomyopathy, Heart Failure, Left Bundle-Branch Block
- Trial name
- LIT-HF (NCT05572957)
- Testing
- Guideline-Directed Medical Therapy(GDMT), left bundle branch pacing combined with Guideline-Directed Medical Therapy(LBBP+GDMT)
- Where
- 6 sites in China
- Volunteers
- 50 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
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
Sleep Apnea, Ventricular Arrythmias
Sleep Apnea-hypopnea Syndrome (SAHS) and Ventricular Arrhythmias
Hypothesis: The CPAP treatment diminishes the effect of ventricular arrhythmias in patients with ischemic heart disease or dilated myocardiopathy, systolic ventricular disfunction and sleep apnea-hypopnea syndrome…
- Conditions
- Sleep Apnea, Ventricular Arrythmias, Systolic Left Ventricle Dysfunction
- Trial name
- SAHS-ICD (NCT00765713)
- Testing
- Nasal continuous positive airway pressure
- Where
- 3 sites in Spain
- Volunteers
- 224 people, healthy volunteers welcome
- Sponsor
- Hospital Universitario La Paz
Myocarditis, Ventricular Arrhythmia
Role of Endomyocardial Biopsy and Aetiology-based Treatment in Pediatric Patients with Inflammatory Heart Disease in Arrhythmic and Non-arrhythmic Clinical Presentations: an Integrated Approach for the Optimal Diagnostic and Therapeutic Management (MYOPED)
Myocarditis is a complex inflammatory disease, usually occurring secondary to viral infections, autoimmune processes or toxic agents.
- Conditions
- Myocarditis, Ventricular Arrhythmia, Inflammatory Cardiomyopathy, Genetic Predisposition
- Trial name
- MYOPED (NCT06591260)
- Testing
- support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation
- Where
- Italy
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Scientific Institute San Raffaele
Implantable Defibrillator User
TRAjectories and CLinical ExpeRiences of ICD Therapy Study
This is a prospective cohort study of older patients receiving implantable cardioverter-defibrillators. The purpose of the TRACER-ICD study is to conduct a prospective cohort investigation with the goal of 500 patients age >65…
- Trial name
- TRACER-ICD (NCT05116176)
- Testing
- Implantable cardioverter-defibrillators
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- Beth Israel Deaconess Medical Center
Implantable Cardioverter Defibrillator(ICD)
To Evaluate the Delivery Timing Safety and Efficacy of AntiTachycardia Pacing (BIO|ATP)
To compare Treatment Group (settings of Early Multiple ATP) and Control Group (settings of extended detection time for the conventional ATP) in Japanese patients, and confirm their safety and efficacy
- Trial name
- BIO|ATP (NCT05426785)
- Testing
- 1:1 ratio for Treatment Group and Control Group
- Where
- Japan
- Volunteers
- 398 people
- Sponsor
- Biotronik SE & Co. KG
Arrhythmia
SOFA: Study on Omega-3 Fatty Acids and Ventricular Arrhythmia
The objective of the SOFA trial is to investigate whether supplemental intake of n-3 polyunsaturated fatty acids (n-3 PUFA) from fish oil can reduce the recurrence of life-threatening ventricular arrhythmias in patients with an…
- Trial name
- NCT00110838
- Where
- 27 sites in Austria, Belgium and 6 more
- Volunteers
- 546 people
- Sponsor
- Wageningen Centre for Food Sciences
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, Implantable Cardioverter Defibrillator (ICD)
PREPARE - Primary Prevention Parameters Evaluation
The purpose of this study is to test specific device programming in patients without a previous history of a life-threatening, abnormally fast heartbeat who are implanted with a Medtronic ICD (Implantable Cardioconverter…
- Conditions
- Tachycardia, Ventricular, Implantable Cardioverter Defibrillator (ICD), Fibrillation, Ventricular, Syncope
- Trial name
- NCT00279279
- Testing
- Implanted Device
- Where
- 32 sites in United States, Puerto Rico
- Volunteers
- 700 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure, Primary Prevention of Sudden Cardiac Death
Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 70 Years
The primary objective of DILEMMA study is to assess whether the "heart failure optimal therapy alone (HFOT)" strategy is non inferior to the "HFOT+ICD" strategy in terms of overall survival 48 months after randomization, in…
- Conditions
- Heart Failure, Primary Prevention of Sudden Cardiac Death, Implantable Cardioverter Defibrillator
- Trial name
- DILEMMA (NCT05373940)
- Testing
- ICD implantation, No ICD implantation
- Where
- 19 sites in France
- Volunteers
- 730 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Arrhythmias, Cardiac, Venous Puncture
Ultrasound Guided Axillary Access vs Standard Fluoroscopic Technique for Cardiac Lead Implantation: ZEROFLUOROAXI TRIAL
Single center, randomized trial (1:1 fashion) to asses the safety and the feasibility of the ultrasound guided venous puncture vs standard fluoroscopic technique in patients undergoing pacemaker or implantable…
- Conditions
- Arrhythmias, Cardiac, Venous Puncture, Implantable Defibrillator User, Pacemaker Complication
- Trial name
- ZEROFLUOROAXI (NCT05101720)
- Testing
- Ultrasound Guided Axillary Venous Access, Fluoroscopy-Guided Axillary Venous Access
- Where
- Italy
- Volunteers
- 280 people
- Sponsor
- University Hospital of Ferrara
Diabetes Mellitus, Heart Failure
Sodium-glucose Co-transporter 2 Inhibitors Effects in Failing Heart Patients
SLGT2 therapy is safety used in heart failure (HF) patients with depressed left ventricle ejection fraction (LVEF) and diabetes mellitus (DM).
- Conditions
- Diabetes Mellitus, Heart Failure, Ventricular Arrythmia
- Trial name
- NCT03977116
- Testing
- SLGT2
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- University of Campania Luigi Vanvitelli
Heart Arrhythmias
Safety of Sports for Patients With Implantable Cardioverter-Defibrillators
The registry will obtain information to determine the safety of sports participation for patients with defibrillators (ICDs).
- Trial name
- NCT00637754
- Where
- 54 sites in United States, Australia and 12 more
- Volunteers
- 400 people
- Sponsor
- Yale University
Defibrillators, Implantable
PET / CT With 18F-FDG: Does it Optimize the I 123-MIBG Imaging Results in the Search for Discriminating Factors for the Implementation of an Implantable Defibrillator?
The main objective of this study is to determine among the patients included a subpopulation that does not need a defibrillator.
- Trial name
- NCT01258283
- Testing
- Addional imaging
- Where
- 2 sites in France
- Volunteers
- 6 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Ventricular Tachycardia, Coronary Artery Disease
Substrate Modification in Stable Ventricular Tachycardia in Addition to Implantable Cardioverter Defibrillator (ICD) Therapy
The main objective of this study is to compare the time from randomization to the first recurrence of any ventricular tachycardia (VT) in patients undergoing VT ablation (for stable VTs) and substrate ablation (for unstable VTs)…
- Conditions
- Ventricular Tachycardia, Coronary Artery Disease, Left Ventricular Dysfunction
- Trial name
- VTACH (NCT00919373)
- Testing
- Substrate modification, VT ablation, ICD Implantation
- Where
- 16 sites in Czechia, Denmark and 2 more
- Volunteers
- 110 people
- Sponsor
- Abbott Medical Devices
Implantable Defibrillator User
Psychological Intervention modifiEs Outcome of Patients With implAntable Cardioverter dEfibrillator: The PEACE Study
This study aims to investigate whether follow-up with a psychologist has an impact on the outcome of patients with an implantable automated defibrillator.
- Trial name
- PEACE (NCT02902458)
- Testing
- Individual interview with a qualified psychologist
- Where
- France
- Volunteers
- 18 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Patient Acceptance of Health Care, Nursing
Mobile Education and Telephone Monitoring for ICD Patients: Effects on Anxiety, Acceptance, and Self-Efficacy
Aim: This study was conducted to determine the effect of a mobile education program and telephone monitoring developed for patients with implantable cardioverter defibrillators (ICD) on shock anxiety, device acceptance, and…
- Conditions
- Patient Acceptance of Health Care, Nursing, Implantable Cardioverter Defibrillator (ICD), Self-Efficacy
- Trial name
- NCT06935526
- Testing
- The mobile training program and telephone follow-ups, Only a two-page summary section of M-ICDEP
- Where
- Turkey (Türkiye)
- Volunteers
- 88 people
- Sponsor
- Akdeniz University
Congestive Heart Failure
External Sensors for remoTe MoniToring of Heart Failure Patients With Implantable Defibrillators
This study has been designed to describe the use of Remote Patient Management (RPM) systems equipped with sensors for the measurement of weight and blood pressure in an Italian health care setting, verifying their efficacy and…
- Trial name
- ESTIMATE-HF (NCT02147340)
- Where
- Italy
- Volunteers
- 186 people
- Sponsor
- Maurizio Eugenio Landolina