The Institutional Review Board (IRB) at the University of Michigan has granted Terumo Heart approval to move forward with the DuraHeart left ventricular assist system (LVAS) U.S. pivotal trial for a bridge-to-transplant (BTT) indication.
Francis Pagani, MD, PhD, director of the adult heart transplantation and artificial devices program at the University of Michigan (UM) in Ann Arbor, will serve as the national co-principal investigator of the U.S. pivotal trial.
UM’s IRB approval is the final step to initiate the DuraHeart LVAS trial following the completion of staff training and equipment delivery, according to the Ann Arbor, Mich.-based Terumo. The university also serves as the primary training site for the trial.
The company said its DuraHeart LVAS Pivotal Trial is a multi-center, prospective, non-randomized study of 140 patients and will include up to 40 centers. Yoshifumi Naka, MD, PhD, from Columbia Presbyterian Hospital in New York City, will serve as the co-principal investigator with Pagani.
The DuraHeart LVAS is a third-generation circulatory support device to provide cardiac support for patients who are at risk of death due to end-stage left ventricular failure, Terumo said. The DuraHeart LVAS, which has the CE Mark, combines a centrifugal pump with magnetic levitation of the impeller.
The DuraHeart LVAS is not available for sale in the U.S.