HeartWare International today announced that the FDA has approved an investigational device exemption (IDE) supplement that allows HeartWare to enroll a second allotment of 54 patients in its ADVANCE bridge-to-transplant clinical trial under a continued access protocol (CAP). The FDA granted an initial allotment of 54 patients in April 2010 and the final patient was implanted under the initial allotment in August 2010.
HeartWare’s ADVANCE clinical trial is an FDA approved IDE study designed to evaluate the HeartWare Ventricular Assist System as a bridge-to-heart transplantation for patients with end-stage heart failure. The primary endpoint of the trial is survival at 180 days, defined as alive on the originally implanted device or transplanted or explanted for recovery.
Under the ADVANCE study, 140 patients at 30 US clinical sites received HeartWare HVAD pumps, making it the largest bridge-to-transplant pivotal trial to date. The final implant in ADVANCE was performed in February 2010, and the last follow-up evaluation at 180 days was in August 2010. Results of the ADVANCE trial are scheduled to be announced as part of a Late-Breaking Clinical Trial session at American Heart Association’s upcoming Scientific Sessions 2010 to be held in Chicago, 13–17 November, 2010. HeartWare currently anticipates submission to the FDA of a pre-market application seeking approval of the HeartWare system for the bridge-to-transplant indication in December of this year.
Patient enrollment under the second CAP can now commence at the 30 centers participating in the ADVANCE clinical trial, subject to Institutional Review Board approvals at the sites.
Separately, the FDA has granted HeartWare full approval for enrollment in its IDE destination therapy clinical trial for the HeartWare Ventricular Assist System. In June 2010, the FDA granted HeartWare conditional approval to begin enrollment in the destination therapy study. Designed to enroll up to 450 patients at 50 US hospitals, the non-inferiority study, which is named ENDURANCE, is a randomised, controlled, unblinded, clinical trial to evaluate the use of the HeartWare Ventricular Assist System as a destination therapy in advanced heart failure patients.