Texas Children's Hospital in Houston will lead a 12-hospital, 36-month clinical trial of a German-manufactured pediatric heart pump.
Dr. Charles Fraser Jr., chief of the hospital's pediatric and congenital heart surgery unit, will serve as the National Principal Investigator for the study of the Berlin Heart EXCOR (extra corporeal) Ventricular Device.
The study will involve 10 U. S. and two Canadian hospitals that will collect and report data to the U. S. Food and Drug Administration on the safety and probable benefit of the pediatric heart pump.
The pump, which comes in graduated sizes to fit newborns to teenagers, is the only pediatric heart pump that provides medium-to-long-term mechanical circulatory support for children awaiting heart transplantations. The device was approved in Germany and Europe in 1972.
"The Berlin Heart is especially attractive as an option for circulatory support in babies and small children awaiting heart transplantation," Fraser said. "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."
Other children's hospitals participating in the study are in Little Rock, Ark.; Boston; Milwaukee; Indianapolis; St. Louis; Seattle; Birmingham, Ala.; Edmonton, Ontario, and Toronto.
Copyright 2008 by United Press International
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