The University of Michigan (U-M) Cardiovascular Center and the University of Pittsburgh Medical Center (UPMC) have been awarded $13.3 million to explore the potential benefits of earlier implantation of left ventricular assist devices (LVADs) in those with less advanced heart failure (HF).
The National Heart, Lung and Blood Institute (NHLBI) and LVAD developer HeartWare International are sponsoring the study.
In REVIVE-IT, researchers will compare whether non-transplant eligible patients with less advanced HF than that of current LVAD recipients do better with the implanted devices than with current medical therapy.
Principal investigators include Keith D. Aaronson, MD, medical director of the heart transplant program and Center for Circulatory Support at the U-M Cardiovascular Center; Francis A. Pagani, MD, PhD, surgical director of the heart transplant program and the Center for Circulatory Support at U-M; and Robert L. Kormos, MD, director of the UPMC Artificial Heart Program and co-director of the UPMC heart transplantation program.
LVADs are currently used in patients with advanced HF as a last resort to help them survive the wait for a heart transplant, or serve as a permanent alternative to heart transplantation, according to the researchers.
"In REVIVE-IT, we'll test the theory that heart failure patients whose condition impairs their daily lives, but who have not suffered serious consequences such as organ damage, malnourishment or immobility, would benefit from earlier implantation of an LVAD," said Kormos.
Kormos also is co-principal investigator of the NHLBI-sponsored Interagency Registry for Mechanical Circulatory Support, which contains information on nearly 2,000 approved assist devices.
The REVIVE-IT study device will be HeartWare's left ventricular assist device the HVAD, a battery-operated continuous blood flow pump that is surgically placed within the heart and the pericardial space surrounding the heart.
The pilot study will include 100 patients from selected U.S. hospitals, including the U-M and UPMC. Site selection for the study will begin this year.