780
Participants
Start Date
October 28, 2024
Primary Completion Date
February 29, 2028
Study Completion Date
December 31, 2028
BrioVAD System
Implantation of the BrioVAD System to evaluate the safety and efficacy of the BrioVAD System by demonstrating non-inferiority to the HeartMate 3 LVAS when used for the treatment of advanced, refractory, left ventricular heart failure.
HeartMate 3
Implantation of the commercially approved HeartMate 3 LVAS, which is the standard treatment for advanced heart failure.
RECRUITING
Montefiore Medical Center, The Bronx
RECRUITING
Duke University, Durham
RECRUITING
Emory University, Atlanta
RECRUITING
UF Health Shands Hospital, Gainesville
RECRUITING
Advent Health, Orlando
RECRUITING
Baptist - Memphis (Stern), Memphis
RECRUITING
Cleveland Clinic, Cleveland
RECRUITING
The Christ Hospital - Cincinnati, Cincinnati
RECRUITING
University of Michigan, Ann Arbor
RECRUITING
Henry Ford Health, Detroit
RECRUITING
Corewell Health Grand Rapids Hospital, Grand Rapids
RECRUITING
Abbott Northwestern Hospital, Minneapolis
RECRUITING
Northwestern University, Chicago
RECRUITING
University of Chicago, Chicago
RECRUITING
Baptist Health Medical Center-Little Rock, Little Rock
RECRUITING
Baylor University Medical Center, part of Baylor Scott & White Health, Dallas
RECRUITING
University of Utah, Salt Lake City
Lead Sponsor
BrioHealth Solutions, Inc.
INDUSTRY