Clinical trials: Implantable Cardioverter Defibrillator
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
Focus Whether After Implant Pre-AICD Video Was Helpful
LifeSkills Video Training in Patients About to Receive an Automatic Implantable Cardioverter-Defibrillator (AICD)
The purpose of this trial was to develop the initial sections of a video/DVD cassette that provided guidance about mastering stressful situations for patients who had been informed that they need an implantable…
- Trial name
- AICD (NCT01686490)
- Testing
- Video/workbook for patients about to receive an AICD, LiveSkills Video/Workbook for patients about to receive an AICD
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Williams LifeSkills
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
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
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
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
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
Pacemaker, Defibrillators, Implantable
Complications Following Pacemaker or Implantable Defibrillator Cardioverter (ICD) Implantation in Denmark
This study examines possible risk factors with regard to complications following pacemaker or implantable defibrillator cardioverter (ICD) implantation.
- Trial name
- NCT01138670
- Where
- Denmark
- Volunteers
- 5,500 people
- Sponsor
- University of Aarhus
Cardiomyopathies
Implantable Cardioverter-Defibrillator Use in the VA System
Despite being a proven life-saving intervention in appropriately selected individuals, multiple studies continue to demonstrate low implantation of defibrillators in potential candidates.
- Trial name
- NCT01217827
- Testing
- Clinical Reminder
- Where
- 2 sites in United States
- Volunteers
- 89 people
- Sponsor
- Stanford University
Heart Failure, Coronary Artery Disease
Same Day Discharge (SDD) After Implantable Cardioverter Defibrillator (ICD) Implant
The purpose of this study is to determine whether it is safe to send patients home from the hospital on the same day following an implantable cardioverter defibrillator (ICD) implant.
- Trial name
- SDD for ICD (NCT01993862)
- Testing
- Same Day Discharge
- Where
- 28 sites in United States
- Volunteers
- 266 people
- Sponsor
- Abbott Medical Devices
Defibrillators, Implantable, Telemedicine
Evaluation of the " Tele-follow-up " for the Follow-up of Implantable Defibrillators
The implantable cardioverter defibrillator (ICD) has been shown to be effective in preventing mortality in patients with ventricular tachyarrhythmia.
- Trial name
- EVATEL (NCT00598026)
- Testing
- Tele- follow-up, Conventional follow-up
- Where
- 30 sites in France
- Volunteers
- 1,501 people
- Sponsor
- Rennes University Hospital
Communication, Heart Failure
An Intervention to Improve Implantable Cardioverter-Defibrillator Deactivation Conversations
An Implantable Cardioverter-Defibrillator (ICD) is a device implanted in a patient's chest to monitor the heart rhythm and deliver shocks to terminate potentially lethal arrhythmias when necessary.
- Trial name
- WISDOM (NCT01459744)
- Testing
- Communication training for cardiologists., Control arm
- Where
- 6 sites in United States
- Volunteers
- 562 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Ventricular Fibrillation, Ventricular Tachycardia
Remote Follow-up of Patients Receiving Implantable Cardioverter Defibrillator for Prophylactic Therapy
The completed MADIT II study has shown that implantation of a cardioverter-defibrillator (ICD) in patients with a reduced left ventricular ejection fraction and a prior myocardial infarction reduces death from any cause.
- Trial name
- REFORM (NCT00401466)
- Testing
- Implantable Cardioverter Defibrillator
- Where
- 5 sites in Czechia, Germany
- Volunteers
- 155 people
- Sponsor
- Biotronik SE & Co. KG
Monomorphic Ventricular Tachycardia
Evaluation of Inducible Monomorphic Ventricular Tachycardia (MMVT) in Patients With St. Jude Medical (SJM) Implantable Cardioverter Defibrillator (ICD) Systems or Cardiac Resynchronization Therapy Defibrillation (CRT-D) Systems.
The intent of this observational study is to understand the role of non-invasive programmed stimulation (NIPS) to induce substrate based MMVT (Monomorphic Ventricular Tachycardia) in patients receiving new St.
- Trial name
- EPIC (NCT02584595)
- Testing
- ICD/CRT-D with NIPS or EP Study
- Sponsor
- Abbott Medical Devices
Brugada Syndrome, S-ICD System (Implantable Defibrillator)
Evaluation of Subcutaneous Implantable Cardiac Defibrillator in Brugada Patients
Brugada syndrome is an inherited arrhythmia syndrome with an increased risk of syncope and sudden death resulting from episodes of polymorphic ventricular tachychardia and fibrillation.
- Trial name
- S-ICD Brugada (NCT02344277)
- Testing
- S-ICD System (implantable defibrillator)
- Where
- 22 sites in Denmark, France and 3 more
- Volunteers
- 130 people
- Sponsor
- Nantes University Hospital
Heart Block, Bradycardia
iPod and Other MP3 Players on ICDs and Pacemakers in Children
Unlike phones, which are commonly held to the ear, music is now available via portable MP3 players and they can be held almost anywhere.
- Conditions
- Heart Block, Bradycardia, Tachycardia, Arrhythmia
- Trial name
- NCT00542854
- Testing
- MP3
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Boston Children's Hospital
Arrhythmias, Cardiac
Clinically Indicated Magnetic Resonance Imaging in Patients With Cardiac Devices
Patients with implanted cardiac devices who meet appropriate entrance criteria undergo clinically indicated Magnetic Resonance (MR) Imaging Studies using an established safety protocol.
- Trial name
- NCT01130896
- Where
- United States
- Volunteers
- 1,509 people
- Sponsor
- Johns Hopkins University
Tachyarrhythmia, Arrhythmias, Cardiac
Surface ECG Signal Recording for the Implantable Subcutaneous String Defibrillator (ISSD) Detection Algorithm Performance Assessment
Recorded cutaneous ECG containing arrhythmia events are separately analysed by an expert Electrophysiologist and the ISSD detection algorithm, to allow assessment of the correct detection of tachyarrhythmia events and…
- Trial name
- NCT03408951
- Testing
- Recording
- Where
- United States
- Volunteers
- 91 people
- Sponsor
- NewPace Ltd
Heart Failure, Systolic
Patient and Physician Survey Determinants of Appropriate ICD Utilization
To better understand the reasons for underutilization of defibrillator therapy in selected populations, the investigators propose a study to assess heart failure patient knowledge and attitudes toward device therapy.
- Trial name
- NCT01514773
- Where
- United States
- Volunteers
- 452 people
- Sponsor
- Todd M Koelling, MD
Cardiomyopathy, Cardiac Arrhythmia
RF Surgical Sponge-Detecting System on the Function of Pacemakers and Implantable Cardioverter Defibrillators
If a surgical sponge is mistakenly left inside a patient's body after a surgical procedure, it can cause a serious infection. To prevent this from happening, a new device has been developed that uses radiofrequency (RF) signals…
- Conditions
- Cardiomyopathy, Cardiac Arrhythmia, Heart Failure, Chronic Thromboembolic Pulmonary Hypertension
- Trial name
- RF (NCT02111980)
- Testing
- RF Assure Scanning
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of California, San Diego