The University of Michigan Frankel Cardiovascular Center announced its first patients has been enrolled in a new expanded indication trial for the CoreValve® Evolut® R System, a minimally invasive treatment for patients with failing aortic heart valves.
Patients randomized in the 1,200-patient trial will be considered low-risk for surgery if, based on an evaluation from a heart team, they have a less than 3 percent risk of death from valve replacement surgery.
The CoreValve Evolut R is a transcatheter aortic valve replacement (TAVR) system that’s only been approved in the United States for high- and extreme-risk patients.
“The trial is designed to assess the safety and performance of a new approach to aortic valve replacement,” says G. Michael Deeb, M.D., Herbert Sloan Collegiate Professor of Surgery and principal investigator for the trial at the U-M.
The Evolut R System is the only next-generation recapturable, self-expanding transcather aortic valve replacement system commercially available in the United States.
The system was designed to increase the potential for optimal device placement during TAVR by providing physicians the option to recapture the valve and reposition it during the procedure as necessary.
The U-M was one of the first heart centers in the country, and the first in Michigan, to use the Evolut R device.
The investigational device exemption trial will enroll low-risk patients from up to 80 clinical sites in the United States with a 1:1 randomization to receive the Evolut R System or undergo open heart surgery.
Study participants have a 50/50 chance of receiving a transcatheter aortic valve if they are a low-risk patient. The IDE is designed as an adaptive trial with a primary endpoint of all-cause mortality or disabling stroke.
Aortic stenosis is a common heart problem caused by a narrowing of the heart’s aortic valve. 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 CoreValve Evolut R System 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 via 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.