Clinical trials: Implantable Cardioverter Defibrillators
Sleep-disordered Breathing, Chronic Heart Failure
Validation of the "ApneaScan" Algorithm for the Detection of Sleep Disordered Breathing in Chronic Heart Failure
A prospective observational multi-centre study for the validation of the ApneaScan algorithm (integrated in ICD devices (with or without cardiac resynchronization therapy function) of the "Incepta" series for the screening of…
- Trial name
- VASA (NCT01979120)
- Where
- 14 sites in Austria, Germany and 2 more
- Volunteers
- 200 people
- Sponsor
- Dr. Christoph Schukro
Heart Failure
CareLink® Network Evaluation
The purpose of the study is to demonstrate the value of the Medtronic CareLink® Network in clinical practice in the country specific healthcare setting.
- Trial name
- NCT01023022
- Testing
- Medtronic CareLink® Network
- Where
- 10 sites in Poland
- Volunteers
- 176 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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, Tachycardia, Ventricular
Effects of Monopolar Electrocautery Use During Surgery on Implanted Cardiac Defibrillators
This observational protocol will evaluate the effects of monopolar electrocautery (ME) on implantable cardioverter defibrillators (ICDs) in patients undergoing surgery.
- Trial name
- NCT01572246
- Testing
- Optimal placement of return pad
- Where
- United States
- Volunteers
- 167 people
- Sponsor
- Oregon Health and Science University
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
Heart Failure With Reduced Ejection Fraction
Comparative Effectiveness of Prophylactic ICD Versus Non-ICD Therapy
The investigators aim to compare the risk of mortality of Non-implantable carioverter defibrillator (ICD) vs. ICD management in patients with heart failure with reduced ejection fraction (HFrEF).
- Trial name
- CONTEMP-ICD (NCT06543446)
- Testing
- ICD implantation
- Where
- 15 sites in United States, Canada
- Volunteers
- 3,290 people
- Sponsor
- University of Rochester
Heart Diseases
A Phase I Study to Assess the Electrophysiologic Effects of BMS-394136 on the Atrium and Ventricle in Patients With Dual-Chamber Pacemakers or Defibrillators
Double-Blind, Randomized, Single-Dose Study to Evaluate the Atrial Selectivity and Safety of BMS-394136 in Subjects with Implanted Dual-Chamber Pacemakers or Defibrillators
- Trial name
- NCT00162448
- Testing
- BMS-394136
- Where
- 3 sites in United States
- Volunteers
- 36 people
- Sponsor
- Bristol-Myers Squibb
Myocardial Infarction, Sudden Death
Efficacy of Implantable Defibrillator Therapy After a Myocardial Infarction
This study will assess whether an implantable defibrillator will increase the likelihood of survival in patients who have had a heart attack, have abnormal test results from a 24 hour heart monitor, and who have low normal heart…
- Trial name
- REFINE-ICD (NCT00673842)
- Testing
- Implantable Cardioverter Defibrillator + Usual Care, Usual care
- Where
- 79 sites in United States, Belgium and 13 more
- Volunteers
- 700 people
- Sponsor
- University of Calgary
Coronary Artery Disease
ST Segment Detection Study
The purpose of ST Detect study is to evaluate whether naturally occurring spontaneous coronary events and exercise induced cardiac ischemia, give rise to detectable changes on intracardiac electrogram (EGM) signals in patients…
- Trial name
- ST Detect (NCT00930969)
- Testing
- ICD
- Where
- 25 sites in United States, Austria and 5 more
- Volunteers
- 175 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
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
Ventricular Arrhythmias and Cardiac Arrest, Implantable Defibrillator User
Targeted Potassium Levels for Prevention of ICD Therapy
This study evaluates whether a rigorously controlled high-normal level of serum-potassium (4.5-5.0 mEq/L) using dietary recommendations, potassium supplements and mineralocorticoid receptor antagonists will results in a lower…
- Conditions
- Ventricular Arrhythmias and Cardiac Arrest, Implantable Defibrillator User, Hypokalemia, Hyperkalemia
- Trial name
- NCT03833089
- Testing
- Targeted serum potassium level
- Where
- 3 sites in Denmark
- Volunteers
- 1,200 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Arrhythmias, Cardiac, Atrioventricular Block
ConTempoRary Cardiac Stimulation in Clinical practicE: lEft, BivEntriculAr, Right, and conDuction System Pacing
The goal of this observational study is to evaluate the clinical characteristics of patients undergoing permanent cardiac pacing and to compare procedural efficacy and safety of different implantation approaches in the clinical…
- Conditions
- Arrhythmias, Cardiac, Atrioventricular Block, Reduced Systolic Function, Atrial Fibrillation
- Trial name
- TREEBEARD (NCT06324682)
- Testing
- Cardiac pacing - Conventional RV pacing, Cardiac pacing - Conduction System Pacing, Cardiac pacing - Cardiac resynchronization therapy (pacing - CRTP - or defibrillation - CRTD)
- Where
- 31 sites in Italy
- Volunteers
- 8,400 people
- Sponsor
- University Hospital of Ferrara
Pacemaker Malfunction, Implantable Defibrillator Malfunction
Cardiac Implantable Electronic Device Magnetic Resonance Imaging Registry
This is a prospective registry evaluating the safety of performing magnetic resonance (MRI) scans on patients who have cardiac implanted electronic devices (CIEDs).
- Trial name
- CIED-MRI (NCT02459379)
- Testing
- MRI Scan
- Sponsor
- NYU Langone Health
Atrial Fibrillation
Sensing Atrial High Rate Episodes With Implantable Cardioverter-Defibrillators Trial (The SENSE Trial)
The primary aim of the "Sensing Atrial High Rate Episodes with DX System in Implantable Cardioverter Defibrillators Trial" (SENSE Trial) is to assess the efficacy of a implantable cardioverter-defibrillator (ICD) lead with…
- Trial name
- SENSE (NCT02186704)
- Testing
- ICD with DX system
- Where
- 8 sites in United States
- Volunteers
- 450 people
- Sponsor
- Weill Medical College of Cornell University
Chronotropic Incompetence, Heart Failure
Rate Adaptive Atrial Pacing in Heart Failure
The ADAPTION trial is an investigator initiated prospective randomized doubleblind cross-over pilot study in a multi-center setting.
- Conditions
- Chronotropic Incompetence, Heart Failure, ICD
- Trial name
- ADAPTION (NCT03235843)
- Testing
- AAIR pacing, DDI-pacing
- Where
- Netherlands
- Volunteers
- 65 people
- Sponsor
- Amsterdam UMC, location VUmc
Liver Cirrhosis
The Use of Fibroscan to Assess Liver Fibrosis in Patients With Cardiac Pacemakers
This study is designed to determine if the Fibroscan (Echosens, Paris), a non-invasive, ultrasound-based device used to estimate fibrosis in patients with chronic liver disease, interferes with implanted cardiac pacemaker and/or…
- Trial name
- NCT02415348
- Testing
- Fibroscan
- Where
- Canada
- Volunteers
- 200 people
- Sponsor
- University of Saskatchewan
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
Ventricular Arrhythmia
Evaluating Ventricular Arrhythmia in Subjects With Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy-Defibrillator
The primary objective of this study is to evaluate the effect of eleclazine (GS-6615) compared to placebo on the overall occurrence of appropriate implantable cardioverter-defibrillator (ICD) interventions (antitachycardia pacing…
- Trial name
- TEMPO (NCT02104583)
- Testing
- Eleclazine
- Where
- 84 sites in United States, Canada and 7 more
- Volunteers
- 313 people
- Sponsor
- Gilead Sciences
Angina Pectoris, Variant, Sudden Cardiac Death
Implantable Cardioverter Defibrillator Versus Optimal Medical Therapy In Patients With Variant Angina Manifesting as Aborted Sudden Cardiac Death
The purpose of this study is to determine whether ICD(Implantable Cardioverter Defibrillator) implantation on the top of optimal medical therapy in patients with variant angina manifesting as aborted sudden cardiac death reduces…
- Trial name
- VARIANT ICD (NCT02845531)
- Testing
- Implantable Cardioverter Defibrillator, Optimal Medical Therapy
- Where
- 26 sites in South Korea
- Volunteers
- 140 people
- Sponsor
- Kee-joon Choi