Clinical trials: Implantable Cardioverter Defibrillators
Arrhythmias
Long Term Safety of 125 mg Per Day of Oral Azimilide in Patients With Implantable Cardioverter Defibrillator (ICDs)
This is an open-label, multi-center, long-term, (open-ended) safety study with 125 mg per day of azimilide in patients who completed protocol 2000098.
- Trial name
- NCT00751738
- Testing
- azimilide dihydrochloride
- Where
- 86 sites in United States, Belgium and 5 more
- Volunteers
- 330 people
- Sponsor
- Forest Laboratories
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 Implantable Electronic Device Infections
Validation of Procalcitonin as a Biomarker Diagnosing CDI
Cardiac device infections (CDI), especially pocket infections, are difficult to be diagnosed. Device pocket infections are not associated with elevated white blood cell count. CRP is only assoziated with a low sensitivity.
- Trial name
- (DIRT II) (NCT05007158)
- Testing
- procalcitonin blood test
- Volunteers
- 200 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Ventricular Arrhythmias
Study of Defibrillation Testing In Patients Undergoing Initial ICD Implantation
The primary objective of this study is to compare the composite outcome of total mortality and operative complications in patients who do not undergo defibrillation testing to those who do undergo defibrillation testing at the…
- Trial name
- TNT-ICD (NCT01905007)
- Testing
- Defibrillation testing
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- The Cooper Health System
Cardiomyopathies, Cardiac Arrhythmias
UMBRELLA - Incidence of Arrhythmias in Spanish Population With a Medtronic Implantable Cardiac Defibrillator (ICD) Implant
The purpose of the study is to analyze the different patient profiles implanted with an Implantable Cardiac Defibrillator (ICD) in Spain (guidelines adoption) and the patient prognosis as a function of clinical profile, implant…
- Conditions
- Cardiomyopathies, Cardiac Arrhythmias, Cardiac Arrest
- Trial name
- UMBRELLA (NCT01561144)
- Where
- 51 sites in Spain
- Volunteers
- 4,648 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Tachycardia, Ventricular, Ventricular Fibrillation
ADVANCE-D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy
The purpose of this study is to estimate and quantify the difference in efficacy of two sequences of ATP therapies (burst 15 pulses, 88% versus burst 8 pulses, 88%) during an episode of spontaneous rhythms classified as fast…
- Trial name
- ADVANCE_D (NCT00147277)
- Testing
- Implantable Cardiac Defibrillator
- Where
- Italy
- Volunteers
- 925 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure, Congestive
PARTNERS HF: Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure
The purpose of this study is to determine the value of diagnostic data obtained from Medtronic implantable cardioverter defibrillators (ICDs) with cardiac resynchronization therapy (CRT) to evaluate cardiovascular and heart…
- Trial name
- NCT00279955
- Testing
- Cardiac Resynchronization Therapy Device
- Where
- 93 sites in United States
- Volunteers
- 1,024 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiac Implantable Electronic Devices
National Tunisian Registry of Cardiac Implantable Electronic Devices
The National Tunisian Registry of Cardiac Implantable Electronic Devices is an observational, prospective and multicenter study aiming to assess the epidemiological, clinical and therapeutic profile of cardiac implantable…
- Trial name
- NATURE-CIED (NCT05361759)
- Testing
- Cardiac Implantable Electronic Devices
- Where
- Tunisia
- Volunteers
- 1,518 people
- Sponsor
- Dacima Consulting
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
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
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
Atrial Tachycardia
PVC Response ''Atrial Pace'' Inducing Atrial Tachycardias
Premature ventricular contractions (PVC) are common phenomenon and occasionally retrograde conduction from ventricle to atrium occurs and may cause pacemaker mediated tachycardia.
- Trial name
- NCT05344456
- Testing
- Change in the device PVC algorithm to ''Off''
- Where
- Finland
- Volunteers
- 16 people
- Sponsor
- Helsinki University Central Hospital
Tachyarrhythmia
Study to Verify Proper Detection of Supraventricular Tachyarrhythmia With Single-Lead Dual-Chamber Implantable Cardioverter-Defibrillators (ADRIA)
A unique single-lead dual-chamber implantable cardioverter-defibrillator (ICD) system (produced by Biotronik, Germany) features a conventional electrode in the ventricle (anchored in the ventricular apex) and a floating electrode…
- Trial name
- NCT00324662
- Testing
- Implantable cardioverter-defibrillator
- Where
- 10 sites in Germany, Switzerland
- Volunteers
- 260 people
- Sponsor
- Biotronik SE & Co. KG
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
Sudden Cardiac Arrest
Nurses Helping Sudden Cardiac Arrest Survivors Recover After Getting An Implantable Cardioverter Defibrillator (ICD)
To determine if an education and support nursing intervention program helped sudden cardiac arrest survivors adjust to the event and to getting an ICD
- Trial name
- NCT00226681
- Testing
- Nursing Telephone Support Protocol, Usual Care
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- National Institute of Nursing Research (NINR)
Ventricular Arrhythmias
Antiarrhythmic Effects of Spironolactone in Patients With ICDs
This study will test whether spironolactone, an approved drug for among other things hypertension, will reduce the risk of severe arrhythmias in patients with implanted defibrillators.
- Trial name
- SPIRIT (NCT04495712)
- Testing
- spironolactone
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- VA Office of Research and Development
Implantable Defibrillator Lead Dysfunction, Implantable Automatic Defibrillator Malfunction
Shock Testing to Unmask RV Lead and GEnerator Malfunction in ICD Patients: the SURGE-ICD Registry
Shock testing during ICD generator replacement has been omitted by many centers. A previous study revealed lead failures in internally cardioverted patients with previously normal HV-lead values.
- Conditions
- Implantable Defibrillator Lead Dysfunction, Implantable Automatic Defibrillator Malfunction, Implantable Defibrillator User
- Trial name
- Surge-ICD (NCT04858672)
- Where
- Germany
- Volunteers
- 300 people
- Sponsor
- Universitätsklinikum Köln
Myocardial Infarction, Heart Failure
A Critical Pathway for Implantable Cardioverter-Defibrillators in Patients With Ischemic Cardiomyopathy
The purpose of this study is to develop and implement a critical pathway to identify patients with ischemic cardiomyopathy who are candidates for an implantable cardioverter-defibrillator (ICD).
- Trial name
- CAPTURE (NCT01248702)
- Testing
- Use of the ICD Critical Pathway
- Where
- Canada
- Volunteers
- 600 people
- Sponsor
- University of British Columbia
Heart Failure, Tachycardia, Ventricular
Optisure Lead Post Approval Study
The purpose of this post approval study is to characterize the chronic performance of the SJM Optisure family of HV leads in patients.
- Trial name
- NCT02235545
- Testing
- St. Jude Medical Optisure Lead
- Where
- 60 sites in United States, Belgium and 5 more
- Volunteers
- 1,735 people
- Sponsor
- Abbott Medical Devices