Chronic Heart Failure Clinical Trial
Official title:
A Prospective, Randomized, Controlled, Unblinded, Multi-Center Clinical Trial to Evaluate the HeartWare™ Ventricular Assist Device System for Destination Therapy of Advanced Heart Failure
This is a prospective, randomized, controlled, unblinded, multi-center evaluation of safety and efficacy in patients implanted with a HeartWare® HVAD who receive improved blood pressure management. Subjects have chronic Stage D or NYHA Class IIIB/IV left ventricular failure who have received and failed optimal medical therapy, and who are ineligible for cardiac transplantation.
The study will evaluate non-inferiority of neurologic injury incidence in a new cohort of subjects receiving improved blood pressure management to a control group (i.e., any FDA-approved LVAD for destination therapy). Secondary endpoints include: a comparison of stroke/TIA incidence to a reference observed in the original IDE clinical trial (HW004) that did not specify improved blood pressure management; and non-inferiority of stroke-free success on the originally implanted device to the control group. Subjects will be randomized to HeartWare® HVAD or control LVAD in a 2:1 ratio. Each subject receiving the HeartWare® HVAD or control LVAD is followed to the primary and secondary endpoints at 12 months, with a subsequent follow-up period extending to 60 months post-implant. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03597646 -
The Effect of Kinesio Taping on Pulmonary Function and Functional Capacity in Patients With Chronic Heart Failure
|
N/A | |
| Terminated |
NCT04065997 -
Apogee International
|
||
| Withdrawn |
NCT03675113 -
Effect of Upper Extremity Aerobic Exercise Training on Exercise Capacity Patients With Chronic Heart Failure
|
N/A | |
| Completed |
NCT02916160 -
Sacubitril-valsartan and Heart Failure Patients : the ENTRESTO-SAS Study
|
Phase 4 | |
| Completed |
NCT03126656 -
Effects of Testosterone on Myocardial Repolarization
|
Phase 4 | |
| Completed |
NCT02268500 -
VAccination to Improve Clinical outComes in Heart Failure Trial: a Feasibility Study (VACC-HeFT)
|
Phase 4 | |
| Completed |
NCT02247245 -
The Influence of Heart Rate Limitation on Exercise Tolerance in Pacemaker Patients.
|
N/A | |
| Completed |
NCT01919918 -
Muscle Afferent Feedback Effects in Patients With Heart Failure
|
Phase 1 | |
| Terminated |
NCT01906957 -
Cognition and Exercise Training
|
N/A | |
| Not yet recruiting |
NCT01669395 -
Severe Heart Failure and Homebased Rehabilitation - An Intersectoral Randomized Controlled Trial
|
N/A | |
| Completed |
NCT00984529 -
Evaluation of Clinical Signs and Symptoms of Chronic Heart Failure in Patients Treated With Candesartan Cilexetil in Croatia
|
N/A | |
| Recruiting |
NCT00863421 -
Sleep Disordered Breathing in Patients With Chronic Heart Failure
|
N/A | |
| Completed |
NCT02840565 -
Tolerability, Pharmacokinetics and Pharmacodynamics of Six Multiple Rising Dose Regimens of BIA 5-453
|
Phase 1 | |
| Completed |
NCT02441218 -
Effects of Ivabradine on Cardiovascular Events in Patients With Moderate to Severe Chronic Heart Failure and Left Ventricular Systolic Dysfunction. A Three-year International Multicentre Study
|
Phase 3 | |
| Completed |
NCT00149409 -
Omega-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Severe Chronic Heart Failure
|
Phase 2/Phase 3 | |
| Terminated |
NCT05532046 -
A Study to Learn How Safe Study Drug BAY2413555 is, How it Affects the Body, and How it Moves Into, Through, and Out of the Body Over 4 Weeks of Use in Participants With Heart Failure and Implanted Cardiac Defibrillator or Cardiac Resynchronization Devices (ICD/CRT)
|
Phase 1 | |
| Recruiting |
NCT04984928 -
Readmission Risk of Patients With Heart Failure.
|
||
| Completed |
NCT02814097 -
A Study to Evaluate the Effects of 4 Weeks Treatment With Subcutaneous Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Preserved Ejection Fraction
|
Phase 2 | |
| Active, not recruiting |
NCT05560737 -
ODYSSEE-vCHAT Mental Health Program for Heart Failure and Kidney Disease Patients
|
||
| Recruiting |
NCT03286127 -
Palliative Outcome Evaluation Muenster I
|