The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) to Thoratec to initiate a feasibility clinical study of its continuous-flow left ventricular assist device (LVAD), for the treatment of Class III heart failure.
Featuring a continuously spinning rotor, the HeartMate II device has an external, wearable system, including a small controller and two batteries, which is attached by a percutaneous driveline.
The device, which pumps up to 10l of blood per minute, is placed just below the diaphragm and is connected to the left ventricle, which carries oxygenated blood to the entire body.
The controlled, prospective trial, named Randomised Evaluation of VAD InterVEntion before Inotropic Therapy (REVIVE-IT), will enrol up to 100 patients to compare the use of the HeartMate II with optimal medical management (OMM) in Class III heart failure patients who are currently not indicated for LVAD support.
University of Pittsburgh Medical Centre (UPMC) artificial heart programme director and UPMC Heart Transplantation programme co-director Robert Kormos said; "These patients suffer from highly impaired quality of life and functional capacity, but their disease has not yet advanced to the point of more serious consequences, such as organ damage or immobility."
Composite measure of survival, freedom from disabling stroke, and improvement in functional outcomes, as measured by the six-minute walk test, are the primary endpoints of the study.
REVIVE-IT study is being sponsored by the National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health and Thoratec, through a $5m contract from the NHLBI and a funding commitment of up to $11m from Thoratec.
Centre for Circulatory Support at University of Michigan Cardiovascular Centre surgical director Francis Pagani said the HeartMate II device has been studied for long-term support of advanced heart failure patients and has a well-defined efficacy and safety profile.
"We look forward to exploring its utilisation and potential benefits, including extended survival and improved functional status, in earlier-stage patients," Pagani said.