Jarvik 2000 Clinical Trials Extended

The Food and Drug Administration has granted the Texas Heart Institute and St. Luke's Episcopal Hospital permission to enroll five additional patients in the Jarvik 2000 clinical trials.

About the size of a "C" battery, the Jarvik 2000 is a valveless, electrically powered miniature axial flow pump that pushes oxygenated blood throughout the body at a rate of up to six liters per minute. At rest, the natural heart pumps three to six liters per minute. The Jarvik 2000 fits directly into the left ventricle, which may lessen problems with clotting. The outflow graft connects to the descending aorta behind the heart.

The device itself does not provide a pulse. As it takes over the work of the failing heart, however, it normalizes and strengthens the native heart function, thereby generating a stronger pulse.

To be eligible for the study, a patient must have end-stage heart failure and be on the transplant waiting list.

"We are pleased with the results of this study so far," said Dr. O.H. Frazier, chief of cardiopulmonary transplantation and director of surgical research at the Texas Heart Institute, and chief of transplant service at St. Luke's Episcopal Hospital. "This extension is attributable to the successful outcomes we have experienced to date with this device."

Four of the five initially approved implantations in the study have been performed. Two study participants have received new hearts and have been discharged. The other two are still waiting for a donor heart.

The Texas Heart Institute at St. Luke's Episcopal Hospital is the only cardiovascular center in the United States conducting these clinical trials of the Jarvik 2000, which has been granted an investigational-device exemption. Jarvik Heart, Inc., and the Texas Heart Institute have been developing the Jarvik 2000 for more than 10 years.

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©2006 Texas Medical Center

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