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FDA approves expansion of clinical trial for left ventricular assist system
Thoratec Corporation announced that it has received approval from the FDA to expand enrollment of the HeartMate III U.S. Clinical trial of a centrifugal-flow chronic left ventricular assist system.
According to a press release, the approval allows for enrollment of as many as 1,028 patients at up to 60 sites. The noninferiority study will evaluate the HeartMate III device, which is intended to reduce the incidence of adverse events in patients with HF, in comparison with the HeartMate II device. The HeartMate III device incorporates a magnetically levitated technology foundation, and is smaller in size in order to simplify surgical placement.
The first 294 patients to be randomly assigned one of the two devices will undergo 6-month follow-up to assess the device as a short-term bridging therapy to transplantation. The first 366 patients will undergo 24-month follow-up to assess HeartMate III as a destination therapy, according to the release.
The primary endpoint is survival without debilitating stroke or need for device replacement. Prespecified secondary endpoints will also be evaluated in approximately 600 additional patients.
The approval for expansion follows safety data from the first 10 patients to receive HeartMate III device during a limited enrollment phase in five sites, according to the release. Thoratec Corporation is also conducting a European study to pursue a CE mark and, pending approval, anticipates commercial release of HeartMate III in Europe late this year.