Medtronic has enrolled the first patient for its EXPAND TAVR II Pivotal Trial, which will evaluate the company’s Evolut transcatheter aortic valve replacement (TAVR) solution as a treatment option for patients with moderate, symptomatic aortic stenosis (AS). This is a patient population typically not indicated for TAVR.
The trial is expected to enroll up to 650 patients from as many as 100 different facilities throughout the world. Patients will be followed for up to 10 years.
The trial’s primary safety endpoint is a composite of all-cause mortality, all-cause stroke, life-threatening or fatal bleeding events, acute kidney injury, device- or procedure-related hospitalizations or valve dysfunction after 30 days. The trial’s primary effectiveness endpoint, meanwhile, is a composite of all-cause mortality, heart failure events or aortic valve replacement/reintervention after two years.
The Evolut TAVR platform is currently approved for the treatment of severe symptomatic aortic stenosis.
“We are thrilled to have the first patient enrolled in this important trial as we assess the performance of the Evolut TAVR platform in new patient populations,” Jeffery Popma, MD, chief medical officer of Medtronic’s Structural Heart and Aortic business, said in a statement. “Demonstrating our leadership in structural heart and continued commitment to generating robust clinical evidence, results from this study will support our clinical strategy to pursue a broader indication of the therapy as we work to treat more patients around the world.”
There have been questions on the long-term durability of TAVR valves, which were expected to wear out more quickly than traditional surgical valves. This is why surgical valve replacement (SAVR) is usually considered the primary option or younger patients, or patients who are not as sick as those with severe aortic stenosis. However, the opposite was found in a recent late-breaking trial at ACC 2022, where the Evolut system showed better durability than SAVR. Read more on that study.
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Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.