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FDA OKs additional patients in ADVANCE trial
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The FDA has granted HeartWare, a device manufacturer of circulatory support technologies, approval to enroll additional patients in its ADVANCE study.
The trial is designed to evaluate HeartWare’s Ventricular Assist System as a bridge-to-transplantation therapy in patients with end-stage HF. According to a press release, the agency approved the addition of up to 54 patients to the original study population of 140 enrolled in the ADVANCE trial with an investigational device exemption supplement.
Under a continued access protocol, enrollment for the additional patients can commence at any of the study’s 30 participating centers, with each enrollment subject to institutional review board.
Patients enrolled under the continuing access protocol will follow a modified protocol of the ADVANCE study. The primary study endpoint is survival at 180 days. Secondary endpoints include adverse events (bleeding and infection) and functional status (hospitalization, assessment of neurocognitive function and patient quality of life). The researchers expect to complete follow-up from the original study population by the end of August.
HeartWare anticipates that it will submit a premarket application for the device to the FDA in December 2010, according to the press release.
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