Newswise — PinnacleHealth recently enrolled the first patient nationally in a new clinical trial investigating a larger size of the Medtronic CoreValve® Evolut® R System—the Evolut R 34mm System. The larger transcatheter aortic valve replacement (TAVR) technology is designed to treat severe aortic stenosis patients with a larger base of the aortic root, called the annulus, specifically those with an annulus diameter between 26-30mm. Annulus sizes vary between individuals.
For many years, the gold standard treatment for severe aortic stenosis has been open surgery. Surgical aortic valve replacement (SAVR) allows the surgeon to clearly visualize and measure the annulus. With TAVR, physicians rely on advanced imaging technology to model the anatomy of the heart, measure the annulus and select the appropriate valve size. With both SAVR and TAVR, accurate sizing is one factor in long-term patient outcomes. TAVR procedures have been limited to patients with a smaller annulus, specifically a diameter less than 26 mm.
The CoreValve Evolut R 34mm Valve 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.
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 new trial for the Evolut R 34mm System at PinnacleHealth is led by Mubashir Mumtaz, MD, FACS, FACC, chief of cardiothoracic surgery and surgical director of structural heart, and Hemal Gada, MD, MBA, medical director of structural heart.
“Participating in this trial allows us to offer TAVR to a subset of patients who formerly had limited treatment options,” says Dr. Mumtaz. “PinnacleHealth continues to be on the forefront of new therapies for patients with aortic stenosis,” says Dr. Gada.
The Medtronic Evolut® 34R U.S. Clinical Study is a prospective, single-arm study that will include 60 patients at up to 15 clinical sites. The study is designed to confirm the safety and efficacy of the CoreValve Evolut R 34mm System and to compare the results to the Evolut R IDE. The prospective study will have a primary safety endpoint of all-cause mortality or disabling stroke at 30 days and primary efficacy endpoints of device success and total regurgitation at 30 days.
The Medtronic Evolut R 34mm System builds off of the CoreValve® Evolut® R transcatheter valve, which was FDA-approved for commercial use in the United States in June 2015 for severe aortic stenosis patients who are at high or extreme risk for surgery.
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