HeartMate® III IDE Study

Protocol: 
AAAN4303

HeartMate® III IDE Study

The HeartMate III Left Ventricular Assist System (LVAS) is a prospective, multi-center, study comparing the HeartMate III LVAS to the HeartMate II® LVAS in advanced stage heart failure patients. The study will be conducted as a staged pivotal study that includes a pre-specified early assessment for safety. Researchers at up to 60 centers will evaluate the device for use as long-term support for patients who are not candidates for cardiac transplant (also known as Destination Therapy). It will also be evaluated for short-term support options, for patients awaiting transplantation (Bridge-to-Transplantation).

Are you Eligible? (Inclusion Criteria)

Advanced Heart Failure New York Heart Association (NYHA) Class III patients with dyspnea upon mild physical activity, or NYHA Class IV who are refractory to advanced heart failure management.

Specialty Area(s)

Trial Location

Columbia University Medical Center
New York, NY 10032
United States