Methodist cardiothoracic surgeon named national PI for trial studying patients with severe aortic stenosisHouston, TX - 4/1/2013
Dr. Michael J. Reardon, a cardiothoracic surgeon with the Methodist DeBakey Heart & Vascular Center, has been named the national surgical principal investigator for the Surgical Replacement and Transcatheter Aortic Valve Implantation (SurTAVI) Trial.
The trial is designed to evaluate the safety and efficacy of the Medtronic CoreValve System in the treatment of patients with severe aortic stenosis who are at an intermediate-risk for surgical aortic valve replacement.
Reardon served on the national steering, screening and publication committees for the first CoreValve trial, which looked at extreme and high-risk patients who were not otherwise candidates for surgery.
“This trial gives us a chance to look at another group of aortic stenosis patients who are searching for a less invasive way to treat their disease,” Reardon said. “A less invasive approach, in most cases, means a shorter hospital stay, and a shorter recovery time for these patients who had few, if any, options before.”
Some 1.5 million Americans suffer from aortic stenosis. More than 500,000 of those suffer from severe aortic stenosis, and 250,000 are symptomatic. Without an aortic valve replacement, more than 50 percent of these people will not survive more than two years after the onset of symptoms.
The study is a large, randomized, controlled study on transcatheter aortic valve implantation (TAVI), looking at 2,500 patients in 75 sites throughout the world. Investigators will study patients with severe and symptomatic aortic stenosis who are at intermediate risk for surgery. Patients will be randomized to either receive a transcatheter aortic valve or undergo standard open surgery. All patients will be followed for five years.
“We believe this trial will allow physicians to study the appropriateness of transcatheter aortic valve replacement in intermediate-surgical risk patients versus standard open surgical aortic valve replacement,” Reardon said. “This trial fits well into our valve program’s minimally invasive options for cardiac valve disease.”
For more information about the SurTAVI Trial, log on to www.debakeyheartcenter.com/valveclinic.