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FDA approves expanded indication trial for self-expanding TAVR system
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The FDA has approved an expanded indication trial to investigate whether a next-generation recapturable, self-expanding transcatheter aortic valve replacement system will be more effective than surgery for patients with aortic stenosis who are at a low surgical mortality risk, as determined by a heart team.
Enrollment for the investigational device exemption (IDE) trial is expected to begin in the second quarter of 2016. The trial will include 1,200 patients with severe aortic stenosis who have a less than 3% risk for mortality. The trial will enroll low-risk patients from up to 80 sites, with 1:1 randomization to receive the CoreValve Evolut R System (Medtronic) or surgical aortic valve replacement, according to a press release.
The IDE trial is designed as an adaptive study with a primary endpoint of all-cause mortality or disabling stroke. The trial has a 2-year endpoint and allows for a 1-year analysis for early FDA submission. The researchers will also perform a substudy of leaflet mobility in 400 patients, according to the release.
“This trial comes on the heels of data showing patients who underwent TAVR with this self-expanding platform demonstrated superior survival benefit — low and stable stroke rates — compared to SAVR patients,” Michael Reardon, MD, professor of cardiothoracic surgery at Houston Methodist DeBakey Heart and Vascular Center and principal investigator of the investigational device exemption study, stated in the release. “This study is an important next step in developing robust clinical evidence to help heart teams understand the potential benefits of TAVR in a broader patient population.”
The CoreValve Evolut R system received FDA approval in June 2015.
Disclosure: Reardon serves on Medtronic’s advisory board.