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National study will look at German-made heart pump for children needing heart transplants

January 21, 2008

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."

Along with Texas Children's Hospital, 11 hospitals will participate in the study: Arkansas Children's Hospital, Little Rock; Boston Children's Hospital; Children's Hospital of Wisconsin in Milwaukee; Riley Children's Hospital, Indianapolis; Mott Children Hospital, Ann Arbor; Lucille Packard Children's at Stanford; St. Louis Children's Hospital; Seattle Children's Hospital; and Children's Hospital at the University of Alabama at Birmingham. Stollery Children's Hospital in Edmonton, and the Hospital for Sick Kids in Toronto are participating in Canada.

In addition to the IDE study, Texas Children's Heart Center has been named the first Berlin Heart Reference and Training Center in the United States - offering support to hospitals not participating in the study who seek to use the Berlin Heart for the first time. Dr. David Morales, pediatric cardiovascular surgeon at Texas Children's and assistant professor, Michael E. DeBakey Department of Surgery at Baylor College of Medicine, will direct a training team comprised of cardiac surgeons, cardiologists, perfusionists, operating room nurses, ICU nurses, research nurses and a designated Berlin Heart Fellow. The team will hold periodic training sessions at Texas Children's, and they will also travel to other hospitals to provide instruction on-site.

"We are delighted to have the exerienced and dedicated team from Texas Children's Heart Center as our first Reference and Training Center in the U.S., said Robert H. Halfmann, MD, director clinical science at Berlin Heart GmbH, Germany. "We are also pleased to work with Dr. Fraser as the NPI for the EXCOR Pediatric IDE trial, which is of great importance to us."

Between 2000 and 2007, prior to FDA approval to begin the study, pediatric hospitals in the U. S. used the Berlin Heart under the FDA's emergency or "compassionate use" regulations. Each time a physician wanted to implant the Berlin Heart in a child dying of heart failure, a special appeal had to be made to the FDA for approval on a case-by-case basis. If approved, the Berlin Heart had to be flown from Germany while the child waited, possibly losing precious time. Also, under prior FDA regulations, the device could not be stored in the U.S., but had to be flown back to Germany if it was not used. Now with the IDE study in place, participating centers may keep the device on hand for easier access for their patients with failing hearts.

BACKGROUND

Physicians in Arizona implanted the first Berlin Heart in the U.S. in 2000. Later, a 4-month-old baby who received the Berlin Heart at Stanford University received high-profile media coverage in August, 2004. The coverage piqued interest in the Berlin Heart among pediatric hospitals around the country. Texas Children's Heart Center implanted its first Berlin Heart on September 27, 2005 in one of the smallest babies to ever receive the device. Currently, Texas Children's has implanted seven Berlin Hearts in infants and young children between the ages of two months to 12 years. Based on his experience with the device, Fraser, a strong advocate of small devices for babies, began working with representatives of the Berlin Heart company in submitting evidence to the FDA. On May 9, 2007, the FDA granted a "Conditional Investigational Device Exemption approval" that allowed for a multi-center study or clinical trial to be set up.

Texas Children's Hospital