FDA Approves U.S. HeartMate III Clinical Trial Expansion
The FDA will expand the initial U.S. clinical trial for the Thoratec Heartmate III based on the safety data from the first 10 implantations, the Pleasanton, Calif. devicemaker said Thursday. The trials will expand to a maximum 1,028 patients across 60 sites for the compact HeartMate III, consisting of a centrifugal-flow chronic left ventricular assist system with a magnetically levitated technology foundation.
Thoratec also announced HeartMate III’s clinical trial coprincipal investigators:
- Dr. Mandeep Mehra, medical director of the Brigham and Women’s Health Heart and Vascular Center, executive director of the Center for Advanced Heart Disease, and professor of medicine at Harvard Medical School;
- Dr. Daniel Goldstein, professor and vice-chairman of the Department of Cardiothoracic Surgery and surgical director of the Mechanical Assistance Program at Montefiore Medical Center;
- Dr. Nir Uriel, associate professor of medicine and medical director of the Heart Failure, Heart Transplant and Mechanical Assist Device Programs of the Division of Cardiology at the University of Chicago; and
- Dr. Joseph Cleveland Jr., professor of surgery and surgical director of Cardiac Transplantation and Mechanical Circulatory Support at the University of Colorado Anschutz Medical Center.
The randomized trial will compare the Heartmate III with the HeartMate II, seeking a survival free of device replacement and debilitating stroke as primary endpoints. The initial 294 patients will be assessed for six months to evaluate short-term indication such as bridge-to-transplantation, while the first 366 patients will be assessed for 24 months to evaluate long-term indication such as destination therapy or permanent use, the devicemaker said.
The FDA-approval also features allowing an additional 600 patients to be enrolled to test prespecified secondary endpoints.
In addition to the U.S. trial, Thoratec completed a CE Mark study enrollment in late 2014, with the hope of receiving European market approval later this year. — Jason Scott