The FDA has approved an investigational device exemption (IDE) supplement that allows HeartWare International to enroll a second allotment of 54 patients in its ADVANCE bridge-to-transplant clinical trial under a continued access protocol (CAP).
The agency granted an initial allotment of 54 patients in April and the final patient was implanted under the initial allotment in August, according to the Sydney, Australia-based company.
The ADVANCE 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.
The final implant in ADVANCE was performed in February, and the last follow-up evaluation at 180 days was in August. HeartWare currently anticipates FDA approval of the HeartWare system for the bridge-to-transplant indication in December.
Patient enrollment under the second CAP can now commence at the 30 centers participating in the ADVANCE trial, subject to Institutional Review Board approvals at these sites.
Results of the ADVANCE trial are scheduled to be announced as part of a Late-Breaking Clinical Trial session at American Heart Association’s 2010 Scientific Sessions to be held in Chicago, Nov. 13-17.