Clinical trials: Implantable Cardiac Defibrillator
Ventricular Tachycardia
Low Energy Therapy to Convert Ventricular Tachycardias
The LEVER study is a prospective, unblinded, non-randomized, first in human feasibility study that will assess and characterize early safety and effectiveness of low energy therapies in converting monomorphic ventricular…
- Trial name
- LEVER (NCT02891863)
- Testing
- LEVER Acute Study System
- Where
- Australia
- Volunteers
- 9 people
- Sponsor
- Boston Scientific Corporation
Sudden Cardiac Arrest
Educational Videos to Improve Patient Decision Making and Race Disparities in Implantable Cardioverter Defibrillator Use
The investigators will examine whether an educational video increases patient knowledge about heart failure and the risk of sudden cardiac arrest and leads to greater satisfaction with information provided as compared to usual…
- Trial name
- VIVID-01 (NCT00918125)
- Where
- 2 sites in United States
- Volunteers
- 59 people
- Sponsor
- Duke University
Ventricular Fibrillation
INSURE: INcidence Free SUrvival Before and After Implantable Cardioverter Defibrillator (ICD) Replacement
The INSURE trial is a multi-center, prospective trial to collect information about adequate ICD therapies in ICD patients before and after their first elective ICD replacement.
- Trial name
- NCT00180440
- Testing
- ICD
- Where
- Germany
- Volunteers
- 528 people
- Sponsor
- Guidant Corporation
Cardiomyopathy, Dilated, 3B
CRT-P or CRT-D in Dilated Cardiomyopathy
The ICD-Reality study is a non-commercial, investigator-led, multicenter, prospective, randomized, controlled trial. We aim to determine the effect of CRT-D or CRT-P implantation in non-ischemic cardiomyopathy and heart failure…
- Trial name
- CRT-REALITY (NCT04139460)
- Testing
- CRT-D, CRT-P
- Where
- Czechia
- Volunteers
- 924 people
- Sponsor
- University Hospital Olomouc
Sudden Cardiac Death, Implantable Defibrillator
SCREENING FOR THE IMPLANTATION OF A SUBCUTANEOUS IMPLANTABLE AUTOMATIC DEFIBRILLATOR
S-ICD (subcutaneous implantable cardioverter-defibrillator) screening failure occurs in about 10% of cases. Predictors of screening failure are not yet well determined.
- Trial name
- SIS (NCT04101253)
- Testing
- new screening procedure with small variations in electrode positioning
- Where
- 16 sites in France
- Volunteers
- 480 people
- Sponsor
- Centre Hospitalier de PAU
Chronic Heart Failure
Interactive Patient's Assistant - LUCY
Patients with chronic heart failure (CHF) and reduced left ventricle ejection fraction benefit from cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillator (ICD).
- Trial name
- NCT03474315
- Testing
- Multivariate assessment
- Where
- Poland
- Volunteers
- 600 people
- Sponsor
- Medical University of Warsaw
Implantable Cardioverter Defibrillator (ICD)
Patient and Partner Intervention After an Implantable Cardioverter Defibrillator (ICD)
The goal of this study is to compare a patient only to a patient+partner intervention on recovery outcomes of patients and partners after Implantable Cardioverter Defibrillator (ICD) implantation.
- Trial name
- P+P (NCT01252615)
- Testing
- patient only, patient and partner intervention
- Where
- United States
- Volunteers
- 301 people
- Sponsor
- University of Washington
Congestive Heart Failure
Effect of Posture on Left Ventricular (LV) Transvenous Lead Capture Thresholds (EXPECT)
The purpose of this study is to determine whether changes in a patient's position affect LV capture thresholds in a clinically significant way.
- Trial name
- EXPECT (NCT01520714)
- Testing
- Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Baylor Research Institute
Prevention of Inappropriate Therapies and MACCE. Single-chamber ICD
Prevention of Inappropriate Therapies and MACCE With a Single Chamber ICD With DX Floating Dipole Atrial Detection
Prevention of inappropriate therapies and serious adverse cardiac and cerebrovascular events with a single chamber implantable defibrillator with DX floating dipole atrial detection
- Trial name
- PREVENT-DX (NCT04344704)
- Testing
- Single chamber DAI device with floating atrial dipole
- Where
- 16 sites in Spain
- Volunteers
- 462 people
- Sponsor
- Trialance SCCL
Heart Failure, Sudden Cardiac Death
Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators
The EVOLVO study is designed to compare the remote defibrillator management to the current standard of care, to assess its ability to treat and triage patients more effectively.
- Conditions
- Heart Failure, Sudden Cardiac Death, Implantable Defibrillator
- Trial name
- EVOLVO (NCT00873899)
- Testing
- The Medtronic CareLink system (Minneapolis, MN, USA).
- Where
- 6 sites in Italy
- Volunteers
- 200 people
- Sponsor
- Regione Lombardia
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
Tachycardia, Ventricular
Bispectral Index Monitoring During Testing in the Electrophysiology Lab
BACKGROUND Physician-guided moderate sedation, administered by a Registered Nurse has been the standard of practice for patients undergoing a wide range of electrophysiology procedures during the past decade.
- Trial name
- NCT00749671
- Testing
- Bispectral index monitoring, Ramsey Sedation Scale
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Baystate Medical Center
Implantable Cardioverter Defibrillator, Atrial Fibrillation
Atrial Sensing Capability for Better Detection of Atrial Fibrillation
This prospective multi-center randomized controlled study aims to compare atrial fibrillation detection and inappropriate therapy according to activation of atrial sensing capability in patients with implantable cardioverter…
- Conditions
- Implantable Cardioverter Defibrillator, Atrial Fibrillation, Cardiac Event, Cardiac Arrhythmia
- Trial name
- NCT03932604
- Testing
- Atrial sensing On mode
- Where
- 28 sites in South Korea
- Volunteers
- 640 people
- Sponsor
- Samsung Medical Center
Arrhythmia
Exercise Training in Patients With Cardioverter-Defibrillators
Exercise therapy has proven to be an effective additive therapy in patients with cardiovascular diseases. The prognostic value of physical activity is well established in patients with congestive heart failure.
- Trial name
- BETA (NCT00754663)
- Testing
- exercise training
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- University Hospital Tuebingen
Myocardial Infarction, Arrhythmia, Ventricular
MASTER II - Microvolt T Wave Alternans Testing for Risk Stratification of Post MI Patients
The purpose of the study is to determine the usefulness of Microvolt T Wave Alternans (MTWA) testing of patients that have had a heart attack and have decreased pumping ability of the lower chamber of their heart.
- Conditions
- Myocardial Infarction, Arrhythmia, Ventricular, Ischemic Cardiomyopathy
- Trial name
- NCT00305214
- Testing
- T Wave Alternans Test
- Where
- 47 sites in United States
- Volunteers
- 405 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Ventricular Tachycardia, Ventricular Fibrillation
Pediatric Lead Extractability and Survival Evaluation (PLEASE)
This is a randomized, prospective clinical trial comparing 2 different types of implantable cardioverter defibrillator (ICD) leads in children and patients with congenital heart disease.
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Cardiomyopathy, Long QT Syndrome
- Trial name
- NCT00335036
- Testing
- ICD lead implant, Thin leads
- Where
- United States
- Volunteers
- 748 people
- Sponsor
- Charles Berul
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
Brugada Syndrome
Hydroquinidine Versus Placebo in Patients With Brugada Syndrome
The specific aim of this study is to determine whether hydroquinidine administration can prevent heart from appearance of ventricular arrhythmia detected by the automatic implantable defibrillator (ICD).
- Trial name
- Quidam (NCT00927732)
- Testing
- hydroquinidine
- Where
- 17 sites in France
- Volunteers
- 64 people
- Sponsor
- Nantes University Hospital
Cardiac Pacemaker Malfunction, ICD Malfunction
Perioperative Management Evaluation in Patients With CIED
Background: Recommendations for peri-operative management in patients with implanted cardiac electronic devices (CIED) are often based on older data from case reports and small collectives.
- Conditions
- Cardiac Pacemaker Malfunction, ICD Malfunction, Cardiac Pacemaker Electrical Interference, Anesthesia Complication
- Trial name
- EVINCE (NCT04331249)
- Testing
- surgery or catheter based cardiac procedure (catheter ablation)
- Where
- 2 sites in Germany
- Volunteers
- 500 people
- Sponsor
- Klinikum-Fuerth
Sudden Cardiac Arrest, Ventricular Tachycardia
A Feasibility Study on Prediction of an ICD Shock by ICD-derived Data
The primary hypothesis is that an ICD shock may be predicted days in advance by a combined score derived from different data obtainable from the ICD
- Conditions
- Sudden Cardiac Arrest, Ventricular Tachycardia, Ventricular Fibrillation
- Trial name
- PREDICT-ICDS (NCT01822145)
- Testing
- ICD
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Princess Margaret Hospital, Hong Kong