Medtronic announced on 21 December 2010 the beginning of its CoreValve US pivotal clinical trial. The first CoreValve transcatheter aortic valve implantation (TAVI) procedure was performed by David H Adams, and Samin K Sharma, at The Mount Sinai Medical Center in New York City.
The Medtronic CoreValve system will be investigated in more than 1,200 patients at up to 40 US clinical trial sites. A second CoreValve case took place this week at El Camino Hospital in Mountain View, California; St Francis Hospital, The Heart Center in Roslyn, NY, also has been activated in the trial and is screening patients.
“Through this trial, we are investigating a minimally invasive, non-surgical alternative to open-heart surgery for valve replacement in patients with severe aortic stenosis,” said Adams, who is chair of the Department of Cardiothoracic Surgery at Mount Sinai and is a national co-principal investigator of the CoreValve US clinical trial. “This study will evaluate the safety and efficacy of the CoreValve system for use in the United States, where many thousands of patients are diagnosed with severe aortic stenosis every year.”
The CoreValve System is designed with self-expandable technology to replace a diseased aortic valve percutaneously, usually through the femoral artery, without open-heart surgery or surgical removal of the native valve. The CoreValve device is delivered through a controlled deployment delivery system.
“We are very excited with this first step in bringing this important transformational therapy to patients in the United States with life-threatening aortic valve disease, particularly those patients who have limited surgical options,” said Jeffrey Popma, national co-principal investigator of the Medtronic CoreValve US pivotal trial and director, Interventional Cardiology at the Beth Israel Deaconess Medical Center in Boston.
The Medtronic CoreValve System with the AccuTrak stability layer will be investigated in two independent studies, evaluating patients who have been deemed at high risk for aortic valve surgery, and those who have been deemed at extreme risk for aortic valve surgery (i.e. inoperable). Clinical sites across the US will be identified on www.clinicaltrials.gov. For more information about the Medtronic CoreValve US clinical trial, see www.aorticstenosistrial.com.