CMS grants Medtronic an IDE clinical trial evaluating its TAVR system

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The Centers for Medicare & Medicaid Services granted an investigational device exemption on May 31 for a trial that will examine Medtronic’s transcatheter aortic valve replacement (TAVR) 2.0 system.

The prospective, single-arm, multicenter study is not yet open for participant recruitment. However, it is expected to enroll patients with severe symptomatic aortic stenosis who are considered at high to extreme risk for surgical aortic valve replacement. Patients are scheduled to be followed through November 2021.

The primary outcomes measures are 30-day all-cause mortality rate, 30-day disabling stroke rate and 30-day rate of participants with none or trace regurgitation on echocardiogram.

Participants will be seen immediately before and after the procedure and at discharge, 30 days, six months and one year. They will then have an annual visit up to the first five years following the procedure.

The co-principal investigators are John Forrest, MD, of the Yale New Haven Hospital, and Mathew Williams, MD, of New York University’s Langone Medical Center.