Clinical trials: Implantable Cardioverter Defibrillators
Arrhythmia, Bradycardia
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
The main purpose of the Product Performance Report (formerly referred to as System Longevity Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm products by analyzing product survival…
- Conditions
- Arrhythmia, Bradycardia, Heart Failure, Sinus Tachycardia
- Trial name
- PPR (NCT00271180)
- Testing
- Device
- Where
- 333 sites in United States, Australia and 33 more
- Volunteers
- 20,000 people
- Sponsor
- Medtronic
Complication of Cardiac Defibrillator
Health Economic Evaluation of Remote Follow up for Implantable Cardioverter Defibrillator (ICD) Patients
The purpose of the study is to define the economic value of implantable cardioverter defibrillator (ICD) remote monitoring for hospitals, third payers and patients in Italy.
- Trial name
- TARIFF (NCT01075516)
- Where
- 6 sites in Italy
- Volunteers
- 209 people
- Sponsor
- Abbott Medical Devices
Implantable Defibrillator User
A Clinical Evaluation of the Durata or Optisure High Voltage Leads and Ellipse VR ICD Undergoing MRI, an IDE Study
To demonstrate safety and efficacy of the Durata or Optisure high voltage lead and Ellipse VR ICD in an MRI environment.
- Trial name
- MRI Ready IDE (NCT02787291)
- Testing
- Ellipse VR ICD and Durata/Optisure lead
- Where
- 32 sites in United States, Hungary and 3 more
- Volunteers
- 227 people
- Sponsor
- Abbott Medical Devices
Tachyarrhythmias, Sudden Cardiac Death
SJ4 Post Approval Study in Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Defibrillator Patients
The purpose of this study is to characterize the chronic performance of the St. Jude Medical SJ4 connector and RV high voltage SJ4 leads.
- Conditions
- Tachyarrhythmias, Sudden Cardiac Death, Heart Failure
- Trial name
- NCT00940888
- Testing
- SJ4 connector and RV high voltage SJ4 lead
- Where
- United States
- Volunteers
- 1,701 people
- Sponsor
- Abbott Medical Devices
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
Monomorphic Ventricular Tachycardia
Evaluation of Inducible Monomorphic Ventricular Tachycardia (MMVT) in Patients With St. Jude Medical (SJM) Implantable Cardioverter Defibrillator (ICD) Systems or Cardiac Resynchronization Therapy Defibrillation (CRT-D) Systems.
The intent of this observational study is to understand the role of non-invasive programmed stimulation (NIPS) to induce substrate based MMVT (Monomorphic Ventricular Tachycardia) in patients receiving new St.
- Trial name
- EPIC (NCT02584595)
- Testing
- ICD/CRT-D with NIPS or EP Study
- Sponsor
- Abbott Medical Devices
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
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
Need for MRI Imaging With Pacemaker or Implantable Cardioverter Defibrillator Implanted
Registry Study of Clinical Application of MRI Compatible CIED
The purpose of this study is to clear the Safety and Necessity of the Magnetic Resonance Imaging (MRI) in the Presence of CIEDs(Cardiovascular Implantable Electronic Devices).
- Trial name
- NCT02380300
- Volunteers
- 2,067 people
- Sponsor
- Biotronik (Beijing) Medical Device Ltd.
Heart Disease, Cardiovascular Disease
Remote Interrogation in Rural Emergency Departments
A retrospective, multi-center, proof-of-concept study to evaluate the use of remote monitoring in rural emergency departments to decrease time to treatment decision for pacemaker and defibrillator patients using the St Jude…
- Conditions
- Heart Disease, Cardiovascular Disease, Heart Failure, Arrhythmias, Cardiac
- Trial name
- REM RED (NCT02421549)
- Testing
- Unpaired remote monitoring transmitter
- Where
- United States
- Sponsor
- Abbott Medical Devices
Heart Failure
REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE)
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
- NCT00271154
- Testing
- Cardiac Resynchronization Therapy (CRT) Device or Implantable Cardioverter Defibrillator (ICD) with CRT
- Where
- 65 sites in United States, Austria and 13 more
- Volunteers
- 684 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Ventricular Arrhythmias
Clinical Investigation of the Medtronic EnTrust™ Implantable Cardioverter Defibrillator (ICD), Model D153ATG
People who have a dangerously fast heart beat, or whose heart is at risk of stopping beating, may be in need of an electronic device called an implantable cardioverter defibrillator (ICD).
- Trial name
- NCT00273195
- Testing
- Implantable Cardioverter Defibrillator
- Where
- 41 sites in United States, Austria and 5 more
- Volunteers
- 500 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Sudden Cardiac Death, Heart Failure
Next Generation INCEPTA Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy (CRT-D) Field Following Study
This study has 2 purposes: The first purpose of the study is to test a new family of Boston Scientific Implantable Cardioverter Defibrillators ("ICDs") and cardiac resynchronization therapy ICDs ("CRT-Ds") and show how well these…
- Trial name
- NOTICE-HF (NCT01227785)
- Testing
- INCEPTA ICD or CRT-D
- Where
- Germany
- Volunteers
- 120 people
- Sponsor
- Guidant Corporation
Arrhythmia
Atorvastatin For The Reduction Of Ventricular Arrhythmias
To assess in patients with CAD [coronary artery disease] and an implantable defibrillator the effect of atorvastatin 80 mg versus placebo on the first recurrence of a ventricular arrhythmia (ventricular tachycardia or ventricular…
- Trial name
- CLARIDI (NCT00457340)
- Testing
- Atorvastatin 80mg
- Where
- 10 sites in Belgium, Greece
- Volunteers
- 220 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Atrial Fibrillation, Atrial Flutter
Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk
The IMPACT Study will investigate the potential clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) technology and a predefined anticoagulation plan compared to conventional device evaluation and…
- Conditions
- Atrial Fibrillation, Atrial Flutter, Stroke, Embolism, Systemic Arterial
- Trial name
- IMPACT (NCT00559988)
- Testing
- Home Monitoring Guided OAC, Physician-Directed OAC
- Where
- 80 sites in United States, Australia and 4 more
- Volunteers
- 2,718 people
- Sponsor
- Biotronik, Inc.
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
Tachycardia
INTRINSIC RV - Inhibition of Unnecessary RV Pacing With AV Search Hysteresis in ICDs
INTRINSIC RV is a two-armed randomized trial that will compare the effects of innovative dual-chamber pacing with AV Search Hysteresis to standard VVI among ICD patients.
- Trial name
- NCT00148967
- Testing
- Implantable Cardioverter Defibrillator
- Volunteers
- 1,535 people
- Sponsor
- Boston Scientific Corporation
Primary Prevention of Sudden Cardiac Arrest, Secondary Prevention of Sudden Cardiac Arrest
S-ICD® System Post Approval Study
The purpose of the S-ICD Post Approval Study is to document long term safety and effectiveness outcomes associated with the implantation of the SQ-RX pulse generator and Q-TRAK electrode in a commercial clinical setting.
- Trial name
- NCT01736618
- Testing
- S-ICD System
- Where
- 87 sites in United States
- Volunteers
- 1,766 people
- Sponsor
- Boston Scientific Corporation
Congestive Heart Failure, Coronary Artery Disease
Autologous Cultured Myoblasts (BioWhittaker) Transplanted Via Myocardial Injection
MyoCell™ implantation by epicardial injection during CABG surgery has the potential to add a new dimension to the management of post-infarct deterioration of cardiac function.
- Conditions
- Congestive Heart Failure, Coronary Artery Disease, Myocardial Infarction
- Trial name
- NCT00050765
- Testing
- MyoCell™ Autologous Myoblasts
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- Bioheart, Inc.