Key issues in trial design for ventricular assist devices: A position statement of the Heart Failure Society of America

A wide array of novel medical devices on the horizon offers promise of substantial clinical benefit to patients with heart failure, including those presently considered to be "end-stage." VADs are an established tool for allowing critically ill patients to undergo cardiac transplant. We have witnessed the first definitive demonstration of survival benefit from VADs as destination devices. Novel advances in VAD design hold the potential for expanding the indication to broader populations and offering improved survival, H-QOL, and device reliability, and/or reduced device-related morbidity. The challenge will be to design clinical trials that will expedite advances in the field, while assuring the safety and efficacy of new devices. Such designs will facilitate the application of new devices as bridges to transplant, as destination therapy, and as instruments for improvement in underlying cardiac pathology.