Clinical trials: Defibrillators, Implantable
Heart Failure, Ischemic Cardiomyopathy
18F-mFBG Imaging for Myocardial Sympathetic Innervation
This is a Phase 2 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for quantification of myocardial sympathetic innervation.
- Conditions
- Heart Failure, Ischemic Cardiomyopathy, ICD Patients
- Trial name
- NCT06965621
- Testing
- 18F-metaFluorobenzylguanidine, Rubidium-82
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)
Heart Failure, Hypertension
Necklace-Shaped Sensor for Non-Invasive Remote Monitoring of Vitals
This study is designed to validate the use of the CoVa Monitoring System in subjects with implanted devices.
- Trial name
- NCT02337790
- Where
- United States
- Volunteers
- 109 people
- Sponsor
- Baxter Healthcare Corporation
Heart Failure
A Phase 1 Trial to Determine Dosimetry, Biodistribution and Safety of LMI 1195-101 in Healthy Subjects and Patients With Heart Failure
The purpose of this clinical study is to estimate the safety and radiation dosimetry of a single dose of LMI1195 in healthy subjects and heart failure patients undergoing positron emission tomography (PET)
- Trial name
- NCT00891241
- Testing
- LMI 1195-101
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Lantheus Medical Imaging
Ventricular Tachycardia, Cardiovascular Diseases
Genetic Substudy of the Alternans Before Cardioverter Defibrillator (ABCD) Trial
The ABCD clinical study (ClinicalTrials.gov Identifier NCT00187291) was designed to determine if a T-Wave Alternans (TWA) test is equivalent to an Electrophysiology Study (EPS) in predicting life-threatening heart rhythms in…
- Conditions
- Ventricular Tachycardia, Cardiovascular Diseases, Arrythmia, CVD
- Trial name
- ABCD (NCT00583297)
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- CardioDx
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
Atrial Fibrillation, Stroke
TRENDS: A Prospective Study of the Clinical Significance of Atrial Arrhythmias Detected by Implanted Device Diagnostics
The purpose of this study is to look at the heart rate and rhythm information collected daily in Medtronic implantable pulse generators (IPG), implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy…
- Conditions
- Atrial Fibrillation, Stroke, Heart Failure
- Trial name
- NCT00279981
- Testing
- Diagnostic
- Where
- 98 sites in United States, Australia and 1 more
- Volunteers
- 3,100 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Implantable Cardioverter Defibrillators, CRT-D Cardiac Resynchronization Therapy Defibrillator
LONGEVITY Study. Evaluation of the Device and Battery Longevity of Boston Scientific Market-released ICD and CRT-D Devices
The study is to determine the rate and cause of device replacements at 5 years post-implantation. It will assess the battery and device longevity of the Implantable Cardioverter Defibrillators (ICD) and CRT-D Cardiac…
- Trial name
- NCT02091011
- Where
- 80 sites in United States, Canada and 6 more
- Volunteers
- 1,600 people
- Sponsor
- Boston Scientific Corporation
Arrhythmia, Quality of Life
Psychosomatic Effects of Implantable Cardioverter Defibrillator With Home Monitoring Function (QUANTUM)
Quality of life (QOL) and psychological well-being of patients with implantable cardioverter-defibrillators (ICDs) are significantly influenced by the experience of shock therapies.
- Trial name
- NCT00325221
- Testing
- HM on, HM Off
- Where
- 7 sites in Austria, Germany and 1 more
- Volunteers
- 148 people
- Sponsor
- Biotronik SE & Co. KG
Ventricular Arrythmia
Shock Efficacy Study Comparing Fixed Tilt and Fixed Pulse Width in a General Implantable-Cardioverter Population
This is a prospective, 1:1 randomized, interventional, multicenter and international trial. Approximately 790 subjects are expected to be enrolled to 40 sites in the south of Europe and Middle East.
- Trial name
- EFICAZ (NCT03632057)
- Testing
- Fixed Tilt (65%), Fixed Pulse Width
- Where
- 2 sites in Spain
- Volunteers
- 779 people
- Sponsor
- Abbott Medical Devices
Tachycardia, Congestive Heart Failure
MADIT-CRT: Multicenter Automatic Defibrillator Implantation With Cardiac Resynchronization Therapy
The MADIT-CRT trial is designed to determine if combined implantable cardiac defibrillator (ICD)-cardiac resynchronization therapy (CRT-D) will reduce the risk of mortality and heart failure (HF) events by approximately 25%, in…
- Trial name
- MADIT-CRT (NCT00180271)
- Testing
- Cardiac resynchronization therapy with defibrillation, Implantable Cardioverter Defibrillator (ICD)
- Where
- United States
- Volunteers
- 1,820 people
- Sponsor
- Boston Scientific Corporation
Cardiac Electrophysiology
Transvenous Lead Removal Post-Market Clinical Study
This prospective, multicenter, post-market clinical study was designed to evaluate the outcomes of lead extraction of cardiovascular implantable electronic devices (CIED) using Cook catheter and lead extraction devices for any…
- Trial name
- NCT03688412
- Testing
- Cook lead extraction devices
- Where
- 9 sites in United States, Germany and 2 more
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- Cook Research Incorporated
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
Heart Failure
Clinical Status Monitoring in Implantable Cardiac Defibrillator (ICD) Patients by Physiological Diagnosis (PhD) Function
The purpose of this study is to evaluate the performance of advanced features, that have been implemented in the PARADYM ICD Platform offering single chamber (VR - model 8250), dual Chamber (DR - 8550) and Cardiac…
- Trial name
- TUTOR (NCT01170624)
- Testing
- ICD
- Where
- 25 sites in Belgium, France and 3 more
- Volunteers
- 388 people
- Sponsor
- LivaNova
Cardiac Rhythm Disorder
3T MRI CIED Post-Approval Study
The purpose of this study is to evaluate product performance of Magnetic Resonance (MR) Conditional Cardiac Implantable Electronic Devices (CIED) following 3 tesla (3T) MRI exposure.
- Trial name
- NCT02969395
- Where
- 204 sites in United States, Belgium and 20 more
- Volunteers
- 41 people
- Sponsor
- Medtronic
Ventricular Fibrillation, Ventricular Tachycardia
Influence of Home Monitoring on the Clinical Status of Heart Failure Patients With an Impaired Left Ventricular Function
Re-hospitalizations or deaths by worsening heart failure are often preceded by distinct trends of clinical parameters such as atrial or ventricular arrhythmia, activity, heart rate variability, or ventricular ectopy.
- Conditions
- Ventricular Fibrillation, Ventricular Tachycardia, Congestive Heart Failure
- Trial name
- IN-TIME (NCT00538356)
- Testing
- ICD or CRT-D with Home Monitoring feature deactivated, ICD or CRT-D with Home Monitoring feature activated
- Where
- 39 sites in Australia, Austria and 5 more
- Volunteers
- 720 people
- Sponsor
- Biotronik SE & Co. KG
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
Sleep Apnoea
Ventricular Arrhythmias Incidence According to Sleep Apnea Syndrome in Implantable Cardioverter-Defibrillator (ICD) Patients
The purpose of this study is to report the incidence of ventricular arrhythmias correlated to the SAS and to focus on the interest of diagnosing Sleep-disorders breathing in ICD patients.
- Trial name
- NCT00708786
- Testing
- ICD, CRT-D
- Where
- 31 sites in France, Germany and 2 more
- Volunteers
- 755 people
- Sponsor
- LivaNova
Tachycardia, Ventricular, Implantable Cardioverter Defibrillator (ICD)
PREPARE - Primary Prevention Parameters Evaluation
The purpose of this study is to test specific device programming in patients without a previous history of a life-threatening, abnormally fast heartbeat who are implanted with a Medtronic ICD (Implantable Cardioconverter…
- Conditions
- Tachycardia, Ventricular, Implantable Cardioverter Defibrillator (ICD), Fibrillation, Ventricular, Syncope
- Trial name
- NCT00279279
- Testing
- Implanted Device
- Where
- 32 sites in United States, Puerto Rico
- Volunteers
- 700 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
Trial to Determine Imaging Parameters of LMI1195 in Heart Failure Patients at Low and High Risk of Defibrillator Firing
The purpose of this clinical study is to determine the optimal imaging parameters and assess the safety of LMI1195 -101 in Heart Failure subjects at Low and High Risk of cardiac events.
- Trial name
- LMI1195-201 (NCT01085175)
- Testing
- LMI 1195
- Where
- United States
- Sponsor
- Lantheus Medical Imaging
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