Clinical trials: Implantable Cardiac Defibrillator
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
Pacemaker DDD, Implantable Defibrillator User
Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices
The Remote Alert Pathway to Optimize Care of Cardiac Implantable Electrical Devices (RAPTOR-CIED) Study is a pragmatic, multi-center, randomized trial with 1:1 patient-level randomization comparing the safety and effectiveness of…
- Trial name
- RAPTOR-CIED (NCT06937658)
- Testing
- Alert-based care, Guideline-based care
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Beth Israel Deaconess Medical Center
Heart Failure
OptiVol® Care Pathway
Medtronic, Inc. is sponsoring the OptiVol® Care Pathway Study, a prospective, randomized, multi-center, post-market clinical trial in the United States.
- Trial name
- NCT00847288
- Testing
- Monthly Review Arm, Quarterly Review Arm
- Where
- 108 sites in United States
- Volunteers
- 1,682 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure, Sudden Death
MIBG Scintigraphy as a Tool for Selecting Patients Requiring Implantable Cardioverter Defibrillator (ICD)
The aim of the study is to assess the cardiac innervation in patients with heart failure to better select candidates for an implantable cardioverter defibrillator.
- Trial name
- MISTIC (NCT01185756)
- Testing
- MIBG for diagnostic purpose
- Where
- France
- Volunteers
- 330 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Implantable Cardiac Device. Patients With a NMR Indication
Patients With Implantable Cardiac Devices Requiring a Nuclear Magnetic Resonance
The general objective of this registry is to study the number of patients carrying an implantable cardiac device that have an indication for an imaging diagnosis based on nuclear magnetic resonance.
- Trial name
- RESONANCE (NCT04330898)
- Testing
- Biotronik peacemakers, implantable cardioverter-defibrillators and cardiac resynchronizers
- Where
- 20 sites in Spain
- Volunteers
- 1,248 people
- Sponsor
- Trialance SCCL
Heart Failure, Nonischemic Cardiomyopathy
Implantable Cardioverter Defibrillator (ICD Registry)
The ICD Registry™ is a nationwide quality program that helps participating hospitals measure and improve care for patients receiving implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy devices…
- Conditions
- Heart Failure, Nonischemic Cardiomyopathy, Ischemic Cardiomyopathy, Ventricular Arrhythmia
- Trial name
- NCT01999140
- Where
- United States
- Volunteers
- 1,750 people
- Sponsor
- American College of Cardiology
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
Arrythmia, Implantable Cardioverter Defibrillator
Clinical and Device Functional Assessment of Real World ICD Patients
The primary requirement of the implantable cardioverter defibrillator (ICD) is to preserve life by terminating life-threatening arrhythmias (VT/VF).
- Trial name
- CARAT (NCT02341768)
- Testing
- ICD
- Where
- 102 sites in Austria, Canada and 10 more
- Volunteers
- 2,056 people
- Sponsor
- MicroPort CRM
Electromagnetic Interference in Cardiovascular Implantable Electronic Device
Electromagnetic Interference and Automobile Remote Keyless Entry in Cardiovascular Implantable Electronic Device (CIED) Patients
Cardiovascular Implantable Electronic device (CIED) is a evolution therapy and number of patients with it are growing rapidly. Electromagnetic interference causing device malfunction is not uncommon, Radiofrequency Identification…
- Trial name
- NCT03016390
- Volunteers
- 100 people
- Sponsor
- Chiang Mai University
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
Congestive Heart Failure
Patient Perspective on Remote Monitoring of Cardiovascular Implantable Electronic Devices
A relatively new and promising development in the area of cardiovascular implantable electronic device therapy is remote patient monitoring (RPM).
- Trial name
- REMOTE-CIED (NCT01691586)
- Testing
- Remote patient monitoring, In-Clinic check-ups
- Where
- Netherlands
- Volunteers
- 600 people
- Sponsor
- UMC Utrecht
HCM - Hypertrophic Cardiomyopathy, S-ICD System (implantable Defibrillator)
An Observational Study of Subcutaneous Implantable Cardioverter Defibrillator in Patients with Hypertrophic Cardiomyopathy At High Risk of Sudden Cardiac Death
1. To observe the failure rate of S-ICD screening in HCM patients at high risk of SCD. 2. To observe the incidence of IAS in HCM patients with S-ICD implantation and explore the related factors of IAS.
- Trial name
- NCT06604169
- Where
- China
- Volunteers
- 589 people
- Sponsor
- China National Center for Cardiovascular Diseases
Sudden Cardiac Death
Ovatio DR and VR Implantable Cardioverter Defibrillators Post-approval Study
The purpose of this post-approval study is to confirm the safety and effectiveness of Ovatio DR and VR ICDs
- Trial name
- Post-Ovatio (NCT00586378)
- Testing
- Ovatio DR and Ovatio VR
- Where
- United States
- Volunteers
- 85 people
- Sponsor
- ELA Medical, Inc.
Heart Failure, Sudden Cardiac Arrest
Symptoms and Coping Strategies Among Patients With Implantable Cardioverter Defibrillator
Implantable cardioverter defibrillators (ICDs) are widely used to prevent sudden cardiac death in patients with serious arrhythmias and significantly increase survival rates.
- Conditions
- Heart Failure, Sudden Cardiac Arrest, Ventricular Arrhythmias
- Trial name
- ICD (NCT07121855)
- Where
- Turkey (Türkiye)
- Volunteers
- 142 people
- Sponsor
- TC Erciyes University
Pacemaker Implantation, Pocket Hematoma and Bleeding
Pocket Haematoma Prevention in Patients Who Required Implantation/Replacement of a Pacemaker or Implantable Cardiac Defibrillator. The PHP Study.
The aim of this study is to demonstrate the efficacy of fibrin sealant (Tissucol-Baxter) in preventing pocket haematoma and subsequent complications in patients undergoing pacemaker or ICD implantation/replacement which cannot…
- Conditions
- Pacemaker Implantation, Pocket Hematoma and Bleeding, Antiplatelet Therapy or Oral Anticoagulants
- Trial name
- PHP (NCT01127984)
- Testing
- tissucol, drainage system
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Careggi Hospital
Myocardial Infarction
Assessment of Spontaneous Baroreflex Sensitivity in Carriers of Implantable Cardioverter Defibrillators: Association With Disorders of the Ventricular Heart Rate. Case-control Study
We must implement 8 implantable cardioverter defibrillators (ICDs) to save a life in 3 years after myocardial infarction (MI) in primary prevention.
- Trial name
- BARODEF (NCT02930382)
- Testing
- Baroreflex assessment
- Where
- France
- Volunteers
- 48 people
- Sponsor
- Poitiers University Hospital
Ventricular Tachycardia, Ventricular Fibrillation
Septal Positioning of Ventricular Implanted Cardioverter Defibrillator (ICD) Leads
This clinical trial is a multi center, prospective, randomized, parallel study designed to compare septal to apical ICD lead placement.
- Trial name
- SPICE (NCT00745745)
- Testing
- Device Implantation
- Where
- 21 sites in Germany, Greece
- Volunteers
- 299 people
- Sponsor
- Abbott Medical Devices
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, Cardiomyopathy
InSync Implantable Cardioverter Defibrillator Registry: Cardiac Resynchronization Therapy
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes.
- Trial name
- NCT00289302
- Testing
- Cardiac resynchronization therapy device
- Where
- 51 sites in United States
- Volunteers
- 600 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Ischaemic Heart Disease, Cardiac Arrhythmia
Effects of a Comprehensive Sexual Rehabilitation Programme in Heart Patients
The objective is to investigate the effect of a comprehensive sexual rehabilitation program, consisting of a psycho-educative component and a physical exercise component.
- Conditions
- Ischaemic Heart Disease, Cardiac Arrhythmia, Sexual Dysfunction
- Trial name
- CopenHeartSF (NCT01796353)
- Testing
- sexual rehabilitation, Usual care
- Where
- Denmark
- Volunteers
- 154 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet