The purpose of the study is to evaluate the safety and effectiveness of the ReliantHeart HeartAssist 5® VAD System in patients listed for heart transplantation and at risk of death from refractory end-stage heart failure.
The HeartAssist 5® VAD System is intended for use as a bridge to heart transplantation and will be compared to the HeartMate II and HVAD devices. Patients that meet the study criteria will be randomized 1:1 to either the HeartAssist 5® VAD System (treatment group) or control group (HeartMate II and HVAD). The physician will have the option to choose which control device to implant. The primary objective of the study is to show non-inferiority of the HeartAssist 5® (treatment group) to the control group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
The HeartAssist 5® VAD System is a small, implantable pump that is designed to increase blood flow for patients who have heart failure. The device is intended to support patients in the hospital or at home.
The HeartMate II® VAD or HVAD®
University of California San Francisco
San Francisco, California, United States
University of Stanford
Stanford, California, United States
The primary endpoint is success at 180 days
Success at 180 days is defined as alive on the original device, transplanted or explanted for heart recovery and alive 60 days after device explant.
Time frame: 180 days
Adverse Events
Device safety will be reported as the frequency of each adverse event, (including device failure, device malfunction or unanticipated adverse device effects) and the rate of adverse events per patient year.
Time frame: 180 days
Quality of Life
Quality of life data, as measured by the EuroQol (EQ-5D) will be summarized and analyzed, for both groups, comparing data at baseline and study intervals.
Time frame: 180 days
Functional Status
NYHA and six-minute walk analysis will be reported by group for data at pre-implant and at study-defined intervals.
Time frame: 180 days
Neurologic Status
Evaluation of any change in Modified Rankin Scale from baseline to 180-days post-implant or device explant.
Time frame: 180 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Miami
Coral Gables, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Indiana University Health, Inc. d/b/a Methodist Research Institute
Indianapolis, Indiana, United States
St. Vincent Hospital & Health Care Center
Indianapolis, Indiana, United States
Jewish Hospital
Louisville, Kentucky, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Mayo Clinic Hospital - Saint Mary's Campus
Rochester, Minnesota, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
...and 4 more locations