Texas Children's Hospital has been named the national lead center for a 12-hospital, 36-month clinical trial of the German-manufactured pediatric heart pump called Berlin Heart EXCOR Pediatric Ventricular Assist Device (VAD).
Charles D. Fraser, Jr., MD, chief of pediatric and congenital heart surgery at Texas Children's and professor, Michael E. DeBakey Department of Surgery at Baylor College of Medicine, will serve as the National Principal Investigator for the Investigational Device Exemption prospective study. As NPI, Fraser will work in cooperation with 10 U. S. hospitals and two Canadian hospitals, in collecting and reporting data to the United States Food and Drug Administration on the safety and probable benefit of the pediatric heart pump. At the study's conclusion, Berlin Heart, Inc. will present those data to the FDA for consideration of approval of the EXCOR Pediatric VAD for use in the U.S.
“The Berlin Heart holds a lot of promise for infants and children whose hearts are failing,” said Fraser. “It's extremely gratifying to be part of such a collaborative study involving the FDA and the other leading heart centers around the nation in exchanging information that will ultimately benefit many pediatric heart patients.”
The Berlin Heart EXCOR Pediatric VAD, which comes in graduated sizes to fit a pediatric population from newborns to teens, is the only pediatric heart pump that provides medium-to-long-term mechanical circulatory support for infants and children awaiting heart transplantations. The device has been approved in Germany and Europe since 1992, but does not have FDA approval for use in the U. S.
“The Berlin Heart is especially attractive as an option for circulatory support in babies and small children awaiting heart transplantation,” said Fraser. A particular advantage is that children can get up, walk around and be kids again while they are recovering and waiting for a donor heart.”