Clinical trials: Device Malfunction
Tachycardia, Ventricular, Heart Failure, Congestive
OMNI Study--Assessing Therapies in Medtronic Pacemaker, Defibrillator, and Cardiac Resynchronization Therapy Devices.
The purpose of the OMNI study is to characterize therapy and diagnostic utilization in study participants implanted with study devices and to describe Implantable Cardioverter Defibrillator(ICD)therapy utilization for life…
- Conditions
- Tachycardia, Ventricular, Heart Failure, Congestive, Ventricular Fibrillation, Ventricular Dysfunction
- Trial name
- OMNI (NCT00277524)
- Where
- 113 sites in United States
- Volunteers
- 3,032 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
Interleukin-1 Receptor Antagonist for the Treatment of Heart Failure in Patients With Left Ventricular Assist Devices
Heart failure remains a major cause of morbidity and mortality. Many patients with heart failure receive support from a left ventricular assist device (LVAD) at some point in the course of their disease.
- Trial name
- NCT02547766
- Testing
- Anakinra
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Utah
End Stage Renal Disease, Acute Kidney Injury
Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients
Hemodialysis is a therapy that filters waste, removes extra fluid and balances electrolytes. In hemodialysis, blood is removed from the body and filtered through a man-made membrane called a dialyzer, and then the filtered blood…
- Conditions
- End Stage Renal Disease, Acute Kidney Injury, Chronic Kidney Disease Stage 5
- Trial name
- ESRD (NCT03539861)
- Testing
- Hemodialysis
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- University of Michigan
Telemedicine, Heart Failure
Electronic Device Implantation Through Remote Guidance
Implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) implants are limited by availability and costs of field clinical specialist (FCS) bioengineers.
- Conditions
- Telemedicine, Heart Failure, Defibrillators
- Trial name
- NCT06404021
- Testing
- interventional cardiology procedures with proctoring system, interventional cardiology procedures with engineer in the electrophysiology laboratory
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- University of Calabria
Heart Failure
Use of Simulation to Improve VAD Self-management
This study will evaluate the performance of a curriculum using medical simulators to train patients with advanced heart failure and their caregivers to master the self-management of ventricular assist devices (a device implanted…
- Trial name
- SimVAD (NCT03073005)
- Testing
- Simulation-based Mastery Learning (SBML)
- Where
- United States
- Volunteers
- 143 people, healthy volunteers welcome
- Sponsor
- Northwestern University
Heart Failure, Cardiomyopathy
Safety & Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Recipients
The main purpose of this research is to determine whether injecting mesenchymal precursor cells (MPC) into the heart during surgery to implant a left ventricular assist device (LVAD) is safe.
- Conditions
- Heart Failure, Cardiomyopathy, Ventricular Dysfunction
- Trial name
- NCT02362646
- Testing
- MPC Intramyocardial Injection, Control Solution
- Where
- 19 sites in United States, Canada
- Volunteers
- 159 people
- Sponsor
- Annetine Gelijns
Smoking, Cigarette
Switching to a Vaping Device: Evaluating Risk Reduction Among Quitline Treatment Failures
The overall aim of the study is to evaluate the provision of e-cigarette (EC) versus NRT on smoking behavior, product use patterns and continued use, and iCO, a biomarker of toxicant exposure, among a sample of recent QL…
- Trial name
- NCT03502200
- Testing
- JUUL, Treatment As Usual
- Where
- United States
- Volunteers
- 350 people, healthy volunteers welcome
- Sponsor
- Ohio State University Comprehensive Cancer Center
Heart Failure
A Study to Assess Safety and Efficacy of a Novel Patch Infusor Device and Novel SUBCUTaneous Furosemide Formulation Combination in Patients With Heart Failure
This is a single-centre, prospective, open-label, non-comparative clinical trial assessing the on-body performance of an investigational drug delivery device (SQIN-Infusor) in patients hospitalised due to HF.
- Trial name
- SUBCUT-HF I (NCT04846816)
- Testing
- SQIN-01
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- SQ Innovation, Inc.
Advanced Heart Failure
Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea
The Korea HM3 PMS is a prospective, single arm, open-label, multi-center, post market surveillance is designed to evaluate clinical and functional outcomes with the HM3 LVAS as a treatment for advanced heart failure.
- Trial name
- NCT04915924
- Testing
- HeartMate 3™ left ventricular assist system (HM3 LVAS)
- Where
- 22 sites in South Korea
- Volunteers
- 358 people
- Sponsor
- Abbott Medical Devices
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
Advanced Heart Failure
Hong Kong and Taiwan HM3 PMS
Hong Kong and Taiwan HM3 PMS is a prospective, single arm, post market surveillance is designed to evaluate clinical and functional outcomes with the HM3 LVAS as a treatment for advanced heart failure.
- Trial name
- NCT04703855
- Testing
- HeartMate 3™ left ventricular assist system (HM3 LVAS)
- Where
- 3 sites in Hong Kong, Taiwan
- Volunteers
- 3 people
- Sponsor
- Abbott Medical Devices
Heart Failure
BOOST - Benefit of Frequent Optimization After Cardiac Resynchronization Therapy Device Replacement
Cardiac resynchronization therapy (CRT) has shown improvement in mortality and morbidity in patients with left ventricular systolic dysfunction and congestive heart failure.
- Trial name
- NCT00929474
- Testing
- QuickOpt - SJM CRT (Group 1), Control - SJM CRT (Group 2)
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- Abbott Medical Devices