El Camino Hospital (Mountain View, USA), in partnership with the Taft Center for Clinical Research and the Fogarty Clinical Research Institute, both a part of the Fogarty Institute for Innovation, announces that it has enrolled its second patient in a global clinical trial comparing the CoreValve System (Medtronic) with surgical aortic valve implantation in patients with severe aortic stenosis who are at intermediate risk for open-heart surgery.
The Medtronic SURTAVI (CoreValve surgical replacement and transcatheter aortic valve implantation) trial is the largest global, randomised, controlled trial to evaluate minimally-invasive TAVI in patients who are not as sick and are typically treated with open-heart surgical aortic valve replacement (SAVR).
El Camino Hospital is one of only 75 clinical sites globally that will enrol approximately 2,500 patients through experienced heart teams including interventional cardiologists and cardiac surgeons. El Camino Hospital’s team is led by co-investigators James Joye, interventional cardiologist at El Camino Hospital, and Vincent Gaudiani, a senior cardiothoracic surgeon and medical staff member at El Camino Hospital.
The trial will evaluate whether the CoreValve System is non-inferior to surgical valve replacement based on the composite primary endpoint of all-cause mortality and disabling stroke at 24 months.
“El Camino Hospital is a leader in advanced procedures for treating various heart conditions,” said Joye. “We are proud to be one of the first centres to enrol a patient in the SURTAVI trial to explore the possibility of a less-invasive treatment option for patients with severe aortic stenosis.”
Currently, the standard treatment for severe aortic stenosis, which affects approximately 300,000 people worldwide, is open-heart valve replacement surgery. However, due to possible health complications, one-third of these patients are considered ineligible for the procedure.
The Medtronic CoreValve System received CE mark in 2007. Since 2007, it has been implanted in more than 30,000 people in more than 60 countries outside the USA. The CoreValve System is currently limited to investigational use in the USA.