This article is more than 5 years old. Information may no longer be current.
REVIVE-IT study of HeartMate II commenced
Click Here to Manage Email Alerts
The FDA has granted an Investigational Device Exemption to commence the REVIVE-IT study, utilizing the HeartMate II Left Ventricular Assist System, according to a press release issued by Thoratec Corporation.
The prospective, randomized, controlled Randomized Evaluation of VAD Intervention Before Inotropic Therapy (REVIVE-IT) trial is designed to compare use of the HeartMate II left ventricular assist device with optimal medical management in patients with NYHA Class III HF. The pilot study will enroll up to 100 patients from leading HF programs in the United States. The primary endpoint of the study is a composite measure of survival, freedom from disabling stroke and improvement in functional outcomes, as measured by the 6-minute walk test, according to the release.
The goal of the feasibility study is to provide initial scientific evidence regarding the potential advantages of mechanical circulatory support therapy in treating earlier-stage, less-ill HF patients who are not indicated for LVAD support, according to the release.
“REVIVE-IT will evaluate the use of the HeartMate II in HF patients currently not indicated for LVAD support. These patients suffer from highly impaired quality of life and functional capacity, but their diseases has not yet advanced to the point of more serious consequences, such as organ damage or immobility,” Robert Kormos, MD, director of the University of Pittsburgh Medical Center Artificial Heart Program and co-director of the UPMC Heart Transplantation Program, stated in the release. Kormos will service as co-principal investigator along with Keith Aaronson, MD, MS, medical director of the heart transplant program and Center for Circulatory Support at University of Michigan Cardiovascular Center, and Francis D. Pagani, MD, PhD, surgical director of the heart transplant program and Center for Circulatory Support.
The HeartMate II continuous-flow LVAD is currently approved by the FDA for both bridge-to-transplantation and destination therapy.
“The HeartMate II device has been extensively studied for long-term support of advanced HF patients and has a very well-defined efficacy and safety profile. We look forward to exploring its utilization and potential benefits, including extended survival and improved functional status, in earlier-stage patients,” Pagani stated.
The REVIVE-IT study is sponsored by Thoratec Corporation and the National Heart, Lung and Blood Institute.