Clinical trials: Defibrillators, Implantable
Ventricular Arrhythmias, Implantable Defibrillator User
Scandinavian Multicenter Study to Advance Risk Stratification in Heart Disease- Ventricular Arrhythmias
The purpose of this study is to identify markers of increased risk for incident ventricular arrhythmias and cardiovascular events in patients already being treated with an implantable cardioverter-defibrillator (ICD) by exploring…
- Conditions
- Ventricular Arrhythmias, Implantable Defibrillator User, Biological Markers, Heart Disease
- Trial name
- SMASH 1 (NCT02864771)
- Where
- Norway
- Volunteers
- 504 people
- Sponsor
- University Hospital, Akershus
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
Defibrillators, Implantable, Electrodes, Implanted
Slew Rate As a Predictor for Optimal Lead Fixation
The goal of this observational study is to identify the most reliable electrical parameter measured at the time of implantation that can predict optimal lead fixation and long-term lead performance in patients undergoing…
- Conditions
- Defibrillators, Implantable, Electrodes, Implanted, Pacemaker, Artificial, Predictive Value of Tests
- Trial name
- SLEW REGISTRY (NCT06842940)
- Where
- Italy
- Volunteers
- 516 people
- Sponsor
- Paolo Pastori, MD
Cardiomyopathy, Coronary Artery Disease
Efficacy and Safety of Implantable Cardioverter-Defibrillator (ICD) Implantation in the Elderly
The overall aim of this trial is to study the safety and efficacy of ICD implantation as a primary prevention strategy of sudden cardiac death in patients 70 years and older.
- Conditions
- Cardiomyopathy, Coronary Artery Disease, Congestive Heart Failure, Myocardial Infarction
- Trial name
- I-70 (NCT02121158)
- Testing
- Implantable Cardioverter Defibrillator, Optimal Medical Therapy
- Where
- 5 sites in United States
- Volunteers
- 167 people
- Sponsor
- VA Office of Research and Development
Arrhythmia, Cardiovascular Diseases
Diagnostic Investigation of Sudden Cardiac Event Risk
The overall objective of the DISCERN study is to develop and validate a genomic diagnostic assay to identify patients at increased risk for lethal ventricular arrhythmias and sudden cardiac death (SCD).
- Conditions
- Arrhythmia, Cardiovascular Diseases, Heart Failure, CVD
- Trial name
- DISCERN (NCT00500708)
- Where
- 8 sites in United States
- Volunteers
- 1,564 people
- Sponsor
- CardioDx
Ventricular Tachycardia, Ischemic Cardiomyopathy
Impact of PREVENTIVE Substrate Ablation of Coronary Chronic Total Occlusion on Implantable cardioVerTer-Defibrillator Interventions
The aim of this study is to assess whether preventive substrate ablation of chronic total occlusion infarct-related artery (CTO-IRA) area in heart failure (HF) patients correlates with lower appropriate implantable cardiac…
- Trial name
- PREVENTIVE VT (NCT03421834)
- Testing
- Catheter ablation of ventricular tachycardia, Optimal medical treatment
- Where
- 5 sites in Croatia, Slovenia
- Volunteers
- 60 people
- Sponsor
- University Medical Centre Ljubljana
Ventricular Tachycardia
Anti-arrhythmic Medication v. MRI-Merge Ablation in the Treatment of Ventricular Tachycardia
Ventricular tachycardia (VT) is a morbid arrhythmia responsible for many sudden deaths and ICD shocks. Despite much progress in the treatment of arrhythmia, VT remains a therapeutic challenge.
- Trial name
- NCT00721032
- Testing
- MRI guided VT ablation, Increased dose of amiodarone
- Where
- United States
- Sponsor
- Johns Hopkins University
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
Cardiovascular Disease
Technology Dependency and Health-Related Quality of Life
This study will explore how people with an implanted cardioverter defibrillator (ICD) feel that dependence on this life-saving technology affects their health-related quality of life.
- Trial name
- NCT00022984
- Where
- United States
- Volunteers
- 125 people
- Sponsor
- National Institutes of Health Clinical Center (CC)
Implantable Cardiac Device. Patients With a NMR Indication
Patients With Implantable Cardiac Devices Requiring a Nuclear Magnetic Resonance
The general objective of this registry is to study the number of patients carrying an implantable cardiac device that have an indication for an imaging diagnosis based on nuclear magnetic resonance.
- Trial name
- RESONANCE (NCT04330898)
- Testing
- Biotronik peacemakers, implantable cardioverter-defibrillators and cardiac resynchronizers
- Where
- 20 sites in Spain
- Volunteers
- 1,248 people
- Sponsor
- Trialance SCCL
Implantable Defibrillator User
Protego DF4 Post Approval Registry
The purpose of this registry study is to confirm the long-term safety and reliability of the Protego DF4 right ventricular lead.
- Trial name
- NCT02243696
- Where
- 68 sites in United States
- Volunteers
- 1,694 people
- Sponsor
- Biotronik, Inc.
Tachycardia, Ventricular, Ventricular Fibrillation
ADVANCE CRT - D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy
To compare the efficacy of RV and BiV ATP for the termination of ventricular arrhythmias in patients who are candidates to a cardiac resynchronisation therapy (CRT) and have a Class I or IIA indication for ICD implantation.
- Trial name
- ADVANCE-CRTD (NCT00147290)
- Testing
- Implantable Cardiac Defibrillator
- Where
- Italy
- Volunteers
- 526 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiomyopathies, Gender
Analysis of Both Sex and Device Specific Factors on Outcomes in Patients with Non-Ischemic Cardiomyopathy
The purpose of this registry is to prospectively assess outcomes of device-treated ventricular tachyarrhythmias and all-cause mortality in non-ischemic cardiomyopathy patients indicated for ICD or CRT-D implantation for the…
- Conditions
- Cardiomyopathies, Gender, Implantable Defibrillator User
- Trial name
- BIO-LIBRA (NCT03884608)
- Where
- 49 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Biotronik, Inc.
Arrhythmia, Tachycardia, Ventricular
Double Blind Placebo Controlled Dose Ranging Study of the Efficacy and Safety of SSR149744c 100 or 300 mg for the Prevention of ventrICular ARrhythmia-triggered Icd interventiOnS
Primary objective: to assess the efficacy of SSR149744C for the prevention of ventricular arrhythmia-triggered ICD interventions.
- Conditions
- Arrhythmia, Tachycardia, Ventricular, Ventricular Fibrillation
- Trial name
- ICARIOS (NCT00232297)
- Testing
- SSR149744C
- Where
- 8 sites in United States, Belgium and 6 more
- Volunteers
- 153 people
- Sponsor
- Sanofi
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
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
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
Hypertrophic Cardiomyopathy
Optimisation of Decision Making for Defibrillator Implantation in Hypertrophic Cardiomyopathy
The main objective of the study is to improve implantable cardioverter defibrillator (ICD) implantation decision-making processing relevance by developing a new prediction model of sudden cardiac death (SCD) in hypertrophic…
- Trial name
- OPTIM-HCM (NCT03846297)
- Where
- France
- Volunteers
- 2,000 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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
Heart Failure, Ventricular Dysfunction
B-Left HF: Biventricular Versus Left Univentricular Pacing With Implantable Cardiac Defibrillator (ICD) Back-Up in Heart Failure Patients
The purpose of this study is to demonstrate that biventricular pacing (BiV) and left univentricular (left ventricular [LV] only) pacing are safe and effective for cardiac resynchronization therapy in heart failure patients…
- Conditions
- Heart Failure, Ventricular Dysfunction, Heart Diseases
- Trial name
- NCT00187213
- Testing
- Cardiac Resynchronization Therapy
- Where
- France
- Sponsor
- Abbott Medical Devices