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Texas Children's Hospital Hosts North American Investigators on Berlin Heart Trial
Date:10/21/2010

stigational device exemption study (IDE). Cohort 1 consisted of 24 babies or young children up to five or six years of age depending on body size.  Cohort 2 involved 24 patients who were six to 16 years old, depending on body size. In September 2010, the Berlin Heart Group announced that enrollment in the IDE trial was complete at 48 patients. The company submitted the results of Cohort 1 to the FDA and expects to submit Cohort 2 soon.  Future patients who need the Berlin Heart will receive treatment under a Continued Access Protocol while the company awaits FDA review of the results and possible approval of the device.

"This is an extremely important milestone in this pivotal study," said Dr. Fraser. "This is the first prospective clinical trial ever conducted to investigate the safety and benefit of a mechanical heart pump designed for children. The data from the trial will be critical in moving the field forward and in offering children with heart failure every possible option."

Study Background

At the end of 2007, Texas Children's Hospital was named the national lead center for a 12-hospital, 36-month clinical trial of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD). In 2008, the study was expanded to include five additional hospitals for a total of 17 centers collecting data on the pump. Cohort 1 is now complete and submitted to the FDA with expectations that data from Cohort 2 will be submitted soon.

Along with Texas Children's Hospital, other hospitals include: Arkansas Children's Hospital, Little Rock; Boston Children's Hospital; Children's Healthcare of Atlanta; Children's Hospital of  Denver; Children's Hospital of Pittsburgh; Children's Hospital of Wisconsin in Milwaukee; Riley Children's Hospital, Indianapolis; Mt. Sinai in New York; Mott Children Hospital, Ann Arbor; Lucille Packard Children's at Stanford; St. Louis Children's Hospital; Seattle Children's Hospital; and Children's H
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