Ascension St. John Hospital has a new expanded indication trial for the Medtronic TAVR System, a minimally invasive treatment for patients with failing aortic heart valves. Ascension St. John Hospital was the first facility in the Midwest to treat a patient as part of the research trial. Patients with severe aortic stenosis who are at a low surgical mortality risk as determined by a heart team will be enrolled in the trial. To date, the technology is commercially approved only for patients with severe aortic stenosis who are considered at high or extreme risk for surgery.
The new trial for Medtronic TAVR in Low Risk Patients at Ascension St. John Hospital is led by cardiologist, Tom Davis, M.D. and Sanjay Batra, M.D., chief of cardiac surgery at Ascension St. John Hospital. The Medtronic TAVR System is the only next-generation recapturable, self-expanding transcatheter aortic valve replacement (TAVR) 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.
“This new study will enable us to determine whether this treatment will be a viable alternative to open heart surgery for a broader patient population,” according to Dr. Davis.
The investigational device exemption (IDE) trial will include 1,256 patients with severe aortic stenosis who have a less than 3 percent risk of mortality, as determined by a heart team. The trial will enroll low-risk patients from up to 80 clinical sites in the United States with 1:1 randomization to receive the Medtronic TAVR System or undergo open-heart surgery (surgical aortic valve replacement or SAVR). 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 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 Medtronic TAVR 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.
The Medtronic family of Valves and Delivery Catheter System were FDA-approved for commercial use in the United States for severe aortic stenosis patients who are at high or extreme risk for surgery.