Clinical trials: Defibrillators
Cardiovascular Disease, Sudden Cardiac Death
Feasibility Testing of Decision Support for Patients Who Are Candidates for an Implantable Defibrillator
Sudden cardiac death (SCD) due to a ventricular arrhythmia is a serious cause of cardiovascular death in Canada. The implantable cardioverter defibrillator (ICD) offers high-risk patients a treatment option to reduce the…
- Trial name
- NCT01876173
- Testing
- Patient Decision Aid for an ICD (primary prevention, non-CRT)
- Where
- Canada
- Volunteers
- 82 people
- Sponsor
- McMaster University
Implantable Cardioverter Defibrillator (ICD)
In-depth Interviews of Patients With ICDs
Although ICDs are effective in preventing sudden cardiac death, they can also profoundly affect patients' and partner/caregivers' emotional well-being, social relationships, and daily functioning.
- Trial name
- QoLICD-INSIGHT (NCT07258602)
- Testing
- semi-structured interview
- Where
- Belgium
- Volunteers
- 250 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Valvular Heart Disease, Implantable Cardioverter Defibrillator
Benefits of ICD for the Primary Prevention in Patients With Valvular Cardiomyopathy
The prevalence of valvular heart disease is on the rise along with the aging society and the generalization of echocardiography.
- Conditions
- Valvular Heart Disease, Implantable Cardioverter Defibrillator, Sudden Cardiac Death, Primary Prevention
- Trial name
- BEAT (NCT03590730)
- Testing
- ICD implantation
- Where
- 12 sites in South Korea
- Volunteers
- 12 people
- Sponsor
- Keimyung University Dongsan Medical Center
Anxiety, Pain
Impact of Virtual Reality on Anxiety and Pain During Implantation of Cardiac Implantable Electronic Devices (CIED)
Purpose: This study aimed to evaluate whether virtual reality technology positively affects patients' pain and anxiety throughout the entire procedure of implantation of cardiac pacemakers, defibrillators, or cardiac…
- Trial name
- CIED (NCT07250282)
- Testing
- Virtual reality headset
- Where
- Germany
- Volunteers
- 111 people
- Sponsor
- Muhammed Kurt
Implantable Cardioverter-defibrillators (ICDs)
Syngery-Evaluating the Impact of Decision Aid
The aim of this study is to determine whether it is better to give patients an implantable cardioverter-defibrillators (ICDs) decision aid before they have their first consultation with an implanting cardiac electrophysiologist…
- Trial name
- NCT03832868
- Testing
- Pre-visit timing of receipt of the ICDs implantation decision aid, Post-visit timing of receipt of the ICDs implantation decision aid
- Where
- 3 sites in United States
- Volunteers
- 25 people
- Sponsor
- Emory University
Congestive Heart Failure
Multiparametric Heart Failure Evaluation in Internal Cardioverter Defibrillators (ICD) Patients
The Boston Scientific Energen family is capable of measuring the respiratory rate trend (RRT) on a daily basis and transmission of data via the Remote Monitoring technology.
- Trial name
- MULTITUDE-HF (NCT01501331)
- Testing
- CRTD or ICD (Energen)
- Where
- 2 sites in Italy
- Volunteers
- 180 people
- Sponsor
- University of Rome Tor Vergata
Heart Failure, Wide QRS Complex
Effect of Rate-responsive Compared to VDD Pacing in Cardiac Resynchronization Therapy Recipients
This study aims to understand the best programming pacing mode for cardiac resynchronization therapy devices used to treat chronic heart failure.
- Trial name
- NCT06592690
- Testing
- Atrial pacing support, Atrial tracking pacing mode
- Where
- Italy
- Volunteers
- 26 people
- Sponsor
- Ospedale Centrale Bolzano
Ventricular Fibrillation, Ventricular Tachycardia
Implantable Cardioverter Defibrillator (ICD) Support Groups and Veterans
In this study, we will compare the quality of life in veterans having ICD who attend the ICD support groups to those who do not.
- Conditions
- Ventricular Fibrillation, Ventricular Tachycardia, Sudden Cardiac Death
- Trial name
- NCT00846417
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- Emory University
Ventricular Tachycardia, Ventricular Fibrillation
First Arrhythmia Collection of Transvenous and Simultaneous Subcutaneous Implantable Defibrillator Data
The purpose of this clinical study is to collect simultaneous, multiple view cardiac signals representing both transvenous ICDs (T-ICD) and sensing vectors from the subcutaneous implantable defibrillator system (S-ICD).
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Atrial Fibrillation
- Trial name
- FACTS (NCT01161589)
- Where
- 4 sites in United States, Netherlands
- Volunteers
- 142 people
- Sponsor
- Boston Scientific Corporation
Primary Prevention of Sudden Cardiac Arrest
Multicenter Automatic Defibrillator Implantation Trial - Reduce Inappropriate Therapy
This study will assess the impact of higher rate cutoffs and longer delays than standard programming on inappropriate therapy in primary prevention ICD and CRT-D patients.
- Trial name
- MADIT-RIT (NCT00947310)
- Testing
- Standard ICD programming, High rate cutoff, Long delay
- Where
- United States
- Volunteers
- 1,500 people
- Sponsor
- Boston Scientific Corporation
Heart Failure, Left Bundle-Branch Block
Resynchronization in Paced Heart Failure Patients With Implantable Cardioverter Defibrillator (ICD) Indication
Today patients with a Cardiac Resynchronization Therapy (CRT) indication usually receive 2 ventricular leads, right ventricular (RV) apex and left ventricular (LV) (postero-) lateral, gaining a responder rate of approximately…
- Trial name
- CRTICD Dual LV (NCT01415024)
- Testing
- second LV lead in CRT
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Schuechtermann-Klinik
Inappropriate Shocks From Implanted Defibrillator, ICD Replacement or Upgrade
Observational Study on Inappropriate Therapies
The purpose of the study is to assess the incidence of inappropriate shocks at 2 years, in a population of patients undergoing a generator replacement (VR/DR/CRT) or upgrade from a previously implanted ICD (VR/DR)
- Trial name
- OSIRIS (NCT04118803)
- Testing
- ICD replacement or upgrade
- Where
- 58 sites in United States, Austria and 9 more
- Volunteers
- 881 people
- Sponsor
- MicroPort CRM
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
Tachyarrhythmias, Sudden Cardiac Death
SJ4 Post Approval Study in Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Defibrillator Patients
The purpose of this study is to characterize the chronic performance of the St. Jude Medical SJ4 connector and RV high voltage SJ4 leads.
- Conditions
- Tachyarrhythmias, Sudden Cardiac Death, Heart Failure
- Trial name
- NCT00940888
- Testing
- SJ4 connector and RV high voltage SJ4 lead
- Where
- United States
- Volunteers
- 1,701 people
- Sponsor
- Abbott Medical Devices
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
Cardiac Arrhythmias, Sudden Cardiac Death
REal World Assessment for Patients Implanted With Implantable CardioverTer DefibrIllatOr Using Bluetooth Technology
The objective of this observational study is to assess clinical benefits of innovative features (e.g. Bluetooth technology and smartphone patient applications) in a patient population that is implanted with standard indication…
- Conditions
- Cardiac Arrhythmias, Sudden Cardiac Death, Heart Failure
- Trial name
- REACTION (NCT05175937)
- Testing
- smartphone APP based remote monitoring, bedside transmitter based remote monitoring
- Where
- Italy
- Volunteers
- 1,104 people
- Sponsor
- Federico II University
Electromagnetic Interference
Safety of Screening Procedures With Hand-held Metal Detectors Among Patients With Implanted Cardiac Rhythm Devices
Patients with implanted pacemaker (PM) or cardioverter-defibrillator (ICD) systems are restrained in daily life by possible electromagnetic interference (EMI).
- Trial name
- NCT01369706
- Testing
- Hand-held metal detector
- Where
- 2 sites in Germany, Greece
- Volunteers
- 388 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Heart Failure
International Study to Determine if AdreView Heart Function Scan Can be Used to Identify Patients With Mild or Moderate Heart Failure (HF) That Benefit From Implanted Medical Device
This is an event-driven Phase IIIb, multicentre, randomised, clinical study to demonstrate the efficacy of AdreView™ imaging for appropriately guiding the decision of implantable cardioverter defibrillator (ICD) implantation, in…
- Trial name
- ADMIRE-ICD (NCT02656329)
- Testing
- Iobenguane I -123 Injection, Implantable Cardioverter Defibrillator, Thyroid blocking
- Where
- 94 sites in United States, Canada and 8 more
- Volunteers
- 395 people
- Sponsor
- GE Healthcare
Tachycardia, Ventricular
S-ICD® System IDE Clinical Study
This clinical study is designed to evaluate the safety and effectiveness of the subcutaneous implantable defibrillator (S-ICD) System.
- Trial name
- NCT01064076
- Testing
- S-ICD System
- Where
- 33 sites in United States, Netherlands and 2 more
- Volunteers
- 330 people
- Sponsor
- Boston Scientific Corporation
Cardiac Arrhythmia
Virtual E-health System for Implantable Cardioverter Defibrillators
This is a Canadian multicenter randomized controlled trial to assess remote patient management. Patients will be randomized to remote patient management with VIRTUES versus usual care, and will be stratified by RemoteView vs no…
- Trial name
- VIRTUES ICD (NCT03405740)
- Testing
- Remote Patient Management, Standard of Care
- Where
- 12 sites in Canada
- Volunteers
- 1,115 people
- Sponsor
- Ratika Parkash