Clinical trials: ICD
HER2/Neu Positive, Recurrent Breast Carcinoma
Vaccine Therapy With or Without Polysaccharide-K in Patients With Stage IV HER2 Positive Breast Cancer Receiving HER2-Targeted Monoclonal Antibody Therapy
This randomized phase I/II trial studies the side effects of vaccine therapy with or without polysaccharide-K and to see how well it works in treating patients with stage IV human epidermal growth factor receptor 2 (HER2)…
- Conditions
- HER2/Neu Positive, Recurrent Breast Carcinoma, Stage IV Breast Cancer
- Trial name
- NCT01922921
- Testing
- HER-2/neu Intracellular Domain Protein, Laboratory Biomarker Analysis, Pertuzumab
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- University of Washington
Tachycardia, Ventricular Arrythmia
ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Japan Study
The study is designed to characterize the acute safety and performance of the EV ICD System for Japanese patients.
- Trial name
- NCT07091916
- Testing
- Defibrillation using the Extravascular ICD
- Where
- Japan
- Volunteers
- 14 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Patient Indicated for an ICD
TRUST: Lumos-T Safely RedUceS RouTine Office Device Follow-up
This study is a multi-center, prospective and randomized trial. The primary objective of this study is to demonstrate that the use of the BIOTRONIK Home Monitoring system (HM) can safely reduce the number of regularly scheduled…
- Trial name
- TRUST (NCT00336284)
- Testing
- Home Monitoring, In-Office Conventional Follow-up
- Where
- 110 sites in United States, Canada
- Volunteers
- 1,450 people
- Sponsor
- Biotronik, Inc.
Tachycardia, Ventricular Arrythmia
Extravascular ICD Pilot Study
The proposed study is designed to characterize the safety and efficacy of a new extravascular implantable cardioverter defibrillator (ICD) system in humans.
- Trial name
- EV ICD (NCT03608670)
- Testing
- Defibrillation using the Extravascular ICD
- Where
- 4 sites in Australia, New Zealand
- Volunteers
- 26 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Arrhythmias, Cardiac
Full Early Atrial Diagnostics in Single Chamber ICD Patients Using the DX Lead and Home Monitoring in Brazil.
To demonstrate the value and benefits of BIOTRONIK's exclusive DX technology in assessing the incidence of supraventricular arrhythmias, mainly atrial fibrillation (AF), in patients with an indication for single chamber ICDs.
- Trial name
- SAFE-DX-Home (NCT04869527)
- Testing
- BIOTRONIK ICDs with DX Technology
- Where
- 2 sites in Brazil
- Volunteers
- 56 people
- Sponsor
- Biotronik SE & Co. KG
ICD, Tachycardia
A Post-market Clinical Evaluation of St. Jude Medical™ MR Conditional ICD System on Patients Undergoing Magnetic Resonance Imaging
To assess the clinical performance of the St. Jude Medical™ MR Conditional ICD System in patients undergoing an elective thoracic MRI scan.
- Trial name
- ASIA MRI ICD (NCT02877693)
- Testing
- Thoracic MRI Scan
- Where
- 20 sites in India, Malaysia and 1 more
- Volunteers
- 205 people
- Sponsor
- Abbott Medical Devices
Tachycardia, Diabetes Mellitus
Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator
The MADIT S-ICD trial was designed to evaluate if subjects with a prior myocardial infarction, diabetes mellitus and a relatively preserved ejection fraction of 36-50% will have a survival benefit from receiving a subcutaneous…
- Conditions
- Tachycardia, Diabetes Mellitus, Cardiovascular Disease
- Trial name
- MADIT S-ICD (NCT02787785)
- Testing
- Subcutaneous Implantable Cardioverter Defibrillator
- Where
- 49 sites in United States, Germany and 5 more
- Volunteers
- 40 people
- Sponsor
- Boston Scientific Corporation
Tachycardia, Ventricular Arrythmia
Extravascular ICD Pivotal Study
Pivotal Summary: The study is designed to demonstrate safety and efficacy of the Extravascular Implantable Cardioverter Defibrillator (EV ICD) System.
- Trial name
- EV ICD (NCT04060680)
- Testing
- Defibrillation using the Extravascular ICD
- Where
- 56 sites in United States, Australia and 15 more
- Volunteers
- 393 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Ventricular Tachycardia, Atrial Fibrillation
AVAI: Atrial Ventricular Arrythmia Incidence
The purpose of this observational study is to collect data regarding the population of patients implanted with St. Jude Medical ICD.
- Trial name
- AVAI (NCT00832975)
- Where
- 2 sites in Spain
- Volunteers
- 157 people
- Sponsor
- Abbott Medical Devices
Myocardiopathies, Ischemia, Myocardial
Extracellular Matrix Marker of Arrhythmia Risk (EMMA)
Assess whether serum levels of MMP 2 and or MMP 9 correlate with episodes of ventricular tachycardia or fibrillation in patients who have implantable cardioverter defibrillator devices.
- Conditions
- Myocardiopathies, Ischemia, Myocardial, Arrythmia, Death, Sudden, Cardiac
- Trial name
- EMMA (NCT00376532)
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- Thomas Jefferson University
Death, Sudden, Cardiac, Ventricular Fibrillation
DISCOVERY: Diagnostic Data and Genetic Polymorphisms in ICD Patients.
To prospectively evaluate if the analysis of genetic polymorphisms can be used to identify patients at risk of ventricular tachycardia.
- Conditions
- Death, Sudden, Cardiac, Ventricular Fibrillation, Tachycardia, Atrial Fibrillation
- Trial name
- DISCOVERY (NCT00478933)
- Testing
- Defibrillator, Dual Chamber ; Implantable, Blood sampling
- Volunteers
- 1,223 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Implantable Defibrillator
Confirmatory Clinical Trial of the Evera MRI System for Conditionally-safe MRI Access
The purpose of the Evera MRI™ study is to confirm safety and efficacy of the Evera MRI ICD (Implantable cardioverter-defibrillator) System in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI…
- Trial name
- NCT02117414
- Testing
- MRI scan sequences of the head and chest regions, Waiting Period Visit
- Where
- 42 sites in United States, Belgium and 11 more
- Volunteers
- 275 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Ventricular Tachycardia
Pilot Study of Catheter Ablation for Ventricular Tachycardia in Patients With an Implantable Cardioverter Defibrillator
The purpose of this pilot trial is to determine the feasibility of a large, multi-center randomized clinical trial aimed to test whether a treatment strategy of percutaneous catheter ablation of ventricular tachycardia (VT) is…
- Trial name
- CALYPSO (NCT01576042)
- Testing
- amiodarone, sotalol, Biosense Webster's NAVI-STAR Thermo-Cool
- Where
- 5 sites in United States
- Volunteers
- 27 people
- Sponsor
- Duke University
Implantable Defibrillator User
Plexa ICD Lead Registry
The purpose of this registry is to confirm the long-term safety and reliability of BIOTRONIK's Plexa ICD lead.
- Trial name
- NCT03103503
- Where
- 28 sites in United States
- Volunteers
- 901 people
- Sponsor
- Biotronik, Inc.
Primary Prevention of Sudden Cardiac Arrest, Secondary Prevention of Sudden Cardiac Arrest
Longitudinal Surveillance Study of the 4-SITE Lead/Header System
Post-approval studies of implanted leads provide an opportunity to observe and assess patient outcomes and technology performance in a real-world setting.
- Trial name
- LSS of 4-SITE (NCT01596595)
- Where
- 111 sites in United States, Australia and 1 more
- Volunteers
- 1,820 people
- Sponsor
- Boston Scientific Corporation
Ventricular Tachycardia (VT)
Pan-Asia United States PrEvention of Sudden Cardiac Death Catheter Ablation Trial
The current standard of care for ventricular tachycardia (VT) includes the use of medicine called anti-arrhythmic drugs (AADs) and Implantable Cardioverter Defibrillator (ICD) therapy.
- Trial name
- PAUSE-SCD (NCT02848781)
- Testing
- Implantable Cardioverter Defibrillator (ICD), Catheter Ablation
- Where
- 12 sites in United States, China and 3 more
- Volunteers
- 180 people
- Sponsor
- University of Arizona
Heart Failure, Obesity
Safety of Body Composition Analysis in Heart Failure Patients With Implantable Cardioverter Defibrillators (ICDs)
The purpose of this study is to define the safety of using bioimpedance for analysis of body composition in heart failure patients with ICD devices.
- Trial name
- NCT01568606
- Testing
- Body Composition Analysis InBody Scale
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of California, Los Angeles
Cardiomyopathy, Heart Failure
Evaluating Myocardial Injury for Defibrillation Threshold Testing Methods for ICD Implantation
The objective of this study is to evaluate myocardial injury, if any, as quantified by cardiac markers (Troponin-T) in defibrillation threshold (DFT) testing during implantation of implantable cardioverter defibrillators (ICDs)…
- Conditions
- Cardiomyopathy, Heart Failure, Cardiac Arrhythmia
- Trial name
- ULV (NCT02111993)
- Testing
- Standard Defibrillation Testing, Upper Limit of Vulnerability Testing
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of California, San Diego
Adrenoleukodystrophy, Metachromatic Leukodystrophy
HSCT for High Risk Inherited Inborn Errors
Hematopoietic stem cell transplantation has proven effective therapy for individuals with adrenoleukodystrophy (ALD), metachromatic leukodystrophy (MLD) or globoid cell leukodystrophy (GLD, or Krabbe disease).
- Conditions
- Adrenoleukodystrophy, Metachromatic Leukodystrophy, Globoid Cell Leukodystrophy, Tay Sachs Disease
- Trial name
- NCT00383448
- Testing
- Clofarabine, Total body Irradiation, Melphalan
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
Tachycardia, Ventricular Fibrillation
Safety and Performance Study of the RELIANCE 4-Front Passive Fixation Lead
The objective of this study is to gather data to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONT™ Passive Fixation Defibrillation Leads.
- Conditions
- Tachycardia, Ventricular Fibrillation, Ventricular Flutter
- Trial name
- NCT01856491
- Testing
- RELIANCE 4-FRONT™ Passive Fixation lead implantation
- Where
- 11 sites in Germany, Israel and 1 more
- Volunteers
- 167 people
- Sponsor
- Boston Scientific Corporation