Clinical study examines new treatment option for aortic stenosis patients with larger valve structure

A clinical trial exploring a new minimally invasive treatment option for some patients with severe aortic stenosis recently launched at Baylor Jack and Jane Hamilton Heart and Vascular Hospital. The investigational treatment option is for patients who might have been previously deemed unable to have transcatheter aortic valve replacement (TAVR) due to the large size of their diseased valves.

The Medtronic CoreValve® Evolut® R 34mm System, which features a larger TAVR technology than previous versions, replaces a diseased aortic heart valve through a minimally invasive procedure, without open-heart surgery and without surgical removal of the diseased valve. The device is typically inserted through an artery in the leg and then guided through the arteries into the heart. Once in place, the device expands and takes over the original valve's function to enable oxygen-rich blood to flow efficiently out of the heart.

Aortic stenosis is a common heart problem caused by a narrowing of the heart's aortic valve due to excessive calcium deposited on the valve leaflets. When the valve narrows, it does not open or close properly, making the heart work harder to pump blood throughout the body. Eventually, this causes the heart to weaken and function poorly, which may lead to heart failure and increased risk for sudden cardiac death.

The investigative larger size CoreValve ® Evolut R® System - the Evolut R 34mm System -- is a recapturable, self-expanding transcatheter aortic valve replacement technology designed to treat severe aortic stenosis in patients with a larger valve structure.

Around 60 patients at up to 15 clinical sites will be enrolled in the prospective, single-arm Medtronic Evolut 34R US Clinical Study. This research is a collaborative effort for Baylor Heart and Vascular Services at Dallas and interventional cardiologists and cardiothoracic surgeons who are designated TAVR team members.

"Our rich history and tradition of being on the forefront of cardiac care continues with this new clinical trial," says Robert Stoler, MD, co-medical director of cardiology and medical director of the cardiac catheterization laboratory at Baylor Heart and Vascular Hospital, and a researcher for Baylor Scott & White Research Institute. "Our patient outcomes and quality care continue to garner national attention. We are pleased to be one of seven clinical sites chosen for this study."