NEW YORK,- JARVIK HEART, Inc., a privately-held company that develops and manufactures cardiac assist devices, announced full FDA approval of its Pivotal Trial for evaluation of the Jarvik 2000® heart for destination therapy (DT) named RELIVE (Randomized Evaluation of Long-term Intraventricular VAD Effectiveness).
Use of the device for DT means that it will provide long-term, permanent support to end-stage congestive heart failure patients who are not candidates for heart transplant. The DT approval permits fifty medical centers to participate in the study. Each medical center may begin enrolling patients immediately upon approval by their Institutional Review Board.
Jarvik Heart recently completed enrollment and follow up to outcome of its 150-patient Bridge to Transplant study. Patients who received the most recent Jarvik 2000 model, using patented cone bearings, show a substantial improvement in the primary endpoint compared to the pin bearing design used earlier in the BTT study. The CAP approval permits 25 patients to receive the Jarvik 2000 over the next year at ten centers that have previously participated in the BTT study.
The DT trial will randomize up to 350 study subjects to either the treatment group, in which patients receive the Jarvik 2000 intraventricular heart assist device, or the control group, in which patients receive the HeartMate II left ventricular assist device (LVAD), the most widely used FDA-approved LVAD for DT.
Patients will be followed for two years to assess primary endpoint success, generally defined as survival free of disabling complications. If the data analysis at two years, or at a prior interim analysis, establishes non-inferiority of the Jarvik 2000 compared to the control, the trial will be judged successful. Additionally, the patients will be followed for another year and the rates of serious infection related to the power cable and pump pocket will be analyzed for the three years since implant. Regarding device-related infection, the analysis is designed to determine if the Jarvik 2000, which uses a unique behind-the-ear power cable and has no pump pocket, is superior to the HeartMate II, which uses an abdominal cable and has an abdominal pump pocket. All DT patients will receive the latest model Jarvik 2000 with cone bearings and the behind-the-ear cable.
PR Newswire