Medtronic on Wednesday announced the first patient enrollment in a global, multicenter, randomized clinical trial comparing Medtronic’s CoreValve transcatheter aortic valve replacement with surgical aortic valve replacement in patients who are considered intermediate risk to undergo open-heart surgery.
The Medtronic CoreValve Surgical Replacement and Transcatheter Aortic Valve
Implantation (SURTAVI) Trial, will evaluate the potential for the minimally-invasive
CoreValve System to be considered for less-sick patients who typically are treated with
open-heart surgical aortic valve replacement (SAVR) today.
The first patient procedures in the SURTAVI trial occurred at Rigshospitalet Copenhagen University Hospital in Copenhagen, Denmark.
“Transcatheter aortic valve replacement is a transformational, potentially lifesaving technology that typically is used to treat inoperable patients or patients for whom surgery carries high risks,” said Patrick Serruys, M.D., Ph.D., professor of medicine and head of the Department of Interventional Cardiology at Erasmus Medical Center in Rotterdam, The Netherlands, and chairman of the SURTAVI trial. “The SURTAVI trial will offer guidance on how to best treat intermediate risk patients and may substantiate the CoreValve System as an attractive alternative treatment for these patients.”
Medtronic said the trial will be the largest global, randomized, controlled trial on transcatheter aortic valve implantation (TAVI) and will evaluate approximately 2,500 patients at up to 75 clinical sites with hear teams that include interventional cardiologists and cardiac surgeons. The trial will evaluate whether the CoreValve System works as well with as surgical valve replacement, based on patient mortality and incidents of major stroke at 24 months. Medtronic is working with the U.S. Food and Drug Administration to include U.S. patients in the trial.
Currently in the United States, only patients considered an extreme risk for open heart surgery are eligible for transcatheter aortic valve replacement, and only a valve Edwards Lifesciences has been approved for use here. But Medtronic has been in the midst of clinical trials for CoreValve’s use with high-risk patients in the U.S. for more than a year.
Outside the U.S., more than 27,000 patients have received CoreValve System implants in more than 60 countries.