Jarvik Heart Inc., a New York-based maker of miniaturized heart assist devices, has received U.S. Food and Drug Administration (FDA) approval for a clinical trial designed to test a ventricular assist device (VAD) for end-stage heart failure patients.

The RELIVE (Randomized Evaluation of Long-term Intraventricular VAD Effectiveness) pivotal trial will test the safety and efficacy of the Jarvik 2000 cardiac assist device over the long term and will be tested at 50 medical centers. The destination therapy 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 destination therapy (DT). DT is the treatment of a heart condition with no goal of eventual heart transplantation.

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 group, the trial will be judged successful. Additionally, 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 behind-the-ear power cable and has no pump pocket, is superior to Thoratec’s 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.

The Jarvik 2000 has been used to treat late-stage heart failure in more than 500 patients in the United States, Europe, and Asia, according to the company. The Jarvik 2000 model with the behind-the-ear connector has supported more than 200 patients in Europe for DT, including the longest survival of any heart assist device patient in the world, seven-and-a-half years.

The bridge-to-transplant model of the Jarvik 2000 has a power cable that exits the abdominal wall—the same position used with the HeartMate II and HeartWare’s VADs. The behind-the-ear cable, which will be used in the DT study, may have significant quality-of-life advantages over abdominal cables. It requires practically no care of the cable exit site and, unlike abdominal cables, does not require frequent redressing with sterile bandages that may require expensive home nursing. Jarvik 2000 patients with the behind-the-ear connector may shower and bathe normally and can even go swimming. In Europe, these patients have had low rates of infection, and there have been no failures of the internal cables and no mechanical failures of the Jarvik 2000 blood pump or its bearings. Long-term bench durability tests project high reliability of the device for 10 years or more.

The cardio device company also is working on child and tiny infant-size pumps with the support of the National Institutes of Health under the “PumpKIN Program”—Pumps for Kids, Infants, and Neonates. The company also is developing new cardiac assists devices intended to enhance patient quality of life.

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