Principal Investigators Announced for St. Jude’s TAVI Trial


September 29, 2010

September 29, 2010 – Physicians from the Cedars-Sinai Heart Institute will lead a clinical trial evaluating transcatheter aortic valve implantation (TAVI) for patients who experience severe aortic stenosis and who may be at an elevated risk for open-heart surgery. The trial will study St. Jude Medical’s transcatheter aortic valve.

The transcatheter aortic valve is designed to offer increased functionality for transfemoral and transapical implantation.

“St. Jude Medical is pleased to have world-renowned physicians directing the clinical research for our TAVI program,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular Division. “Dr. Gregory Fontana and Dr. Raj Makkar have been extensively involved in previous research efforts pertaining to transcatheter aortic valve implantation and are leading authorities for these technologies. We believe this is an important milestone for our program.”

Raj Makkar, M.D., director of interventional cardiology and associate director of the Cedars-Sinai Heart Institute in Los Angeles, has extensive experience in high-risk percutaneous coronary and valvular interventions and the use of advanced percutaneous circulatory support devices. Under Makkar’s direction, Cedars-Sinai physicians completed the most aortic valve replacements in an international clinical trial at more than 20 medical centers. He is a principal investigator for several research protocols involving transcatheter interventions and devices.

Gregory Fontana, M.D., is a cardiac surgeon at the Cedars-Sinai Heart Institute and has been a principal investigator for several research protocols involving transcatheter interventions and minimally invasive surgical devices. As a widely published researcher and author, his writings include more than 80 academic works appearing as articles, book chapters, abstracts and reviews. Published subject matter includes treatments for diseases of the coronary arteries, heart valves, heart transplantation and congenital heart defects.

The St. Jude Medical transcatheter heart valve, made of pericardial tissue, is designed to increase physicians’ control and accuracy during valve deployment. Two delivery methods for the St. Jude Medical transcatheter valve will be evaluated in the trial, the transfemoral and the transapical systems, which are both designed to make transcatheter valve deployment and retrieval easier for clinicians.

The European clinical trial of the St. Jude Medical transcatheter aortic valve is expected to start in 2011.

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