St. Jude Medical has announced that physicians from the Cedars-Sinai Heart Institute in Los Angeles will lead the company's transcatheter aortic valve implantation (TAVI) clinical trial.
The study will evaluate the safety and efficacy of St. Jude’s transcatheter aortic valve for patients who experience severe aortic stenosis and who may be at an elevated risk for open heart surgery, the St. Paul, Minn.-based company said. St. Jude's transcatheter heart valve, made of pericardial tissue, can be delivered via two methods that will be evaluated in the trial—transfemorally and transapically.
St. Jude said the principal investigators are:
- Raj Makkar, MD, director of interventional cardiology and associate director of Cedars-Sinai Heart, who has experience in high-risk PCI and valvular interventions and the use of percutaneous circulatory support devices. He is a principal investigator for several research protocols involving transcatheter interventions and devices.
- Gregory Fontana, MD, a cardiac surgeon at Cedars-Sinai Heart, who has been a principal investigator for research protocols involving transcatheter interventions and minimally invasive surgical devices. Fontana's writings include more than 80 academic works appearing as articles, book chapters, abstracts and reviews on treatments for diseases of the coronary arteries, heart valves, heart transplantation and congenital heart defects.
The European clinical trial of St. Jude's transcatheter aortic valve is expected to start in 2011.