The US Food and Drug Administration (FDA) has given approval to Jarvik Heart to initiate the RELIVE (Randomized evaluation of long-term intraventricular VAD effectiveness) pivotal trial for the evaluation of the company’s Jarvik 2000 heart for destination therapy.
Use of the device for destination therapy means that it will provide long-term, permanent support to end-stage congestive heart failure patients who are not candidates for heart transplant. Fifty medical centres will participate in the trial. The study will randomise up to 350 patients 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.
Patients will be followed for two years to assess survival free of disabling complications as primary endpoint. 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 analysed 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.
According to a company release, the Jarvik 2000 has been used to treat late-stage heart failure in more than 500 patients in the United States, Europe, and Asia. The Jarvik 2000 model with the behind-the-ear connector has supported more than 200 patients in Europe for destination therapy, including the longest survival of any heart assist device patient in the world, 7½ 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 VADs. The behind-the-ear cable, which will be used in the destination therapy 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 ten years or more.