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Post-market trial of self-expanding TAVR system begun

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Medtronic announced a post-market clinical trial of longer-term performance for its self-expanding transcatheter aortic valve replacement system designed to improve valve sealing performance.

The valve (CoreValve Evolut PRO) was recently approved in Europe and the U.S. for treatment of severe symptomatic aortic stenosis in patients at an intermediate, high or extreme risk for heart surgery.

The trial aims to enroll 600 patients across 35 sites in Europe.

The researchers will assess safety by all-cause mortality and all stroke at 30 days and clinical performance including valve hemodynamics and paravalvular regurgitations for up to 5 years.

“We look forward to replicating the excellent clinical outcomes demonstrated by the Evolut PRO valve in a study designed to look at the valve’s longer-term real-world performances,” Eberhard Grube, MD, director of the Structural Heart Program at University Hospital in Bonn, Germany, said in the release. “The Evolut PRO has shown exceptional results for patients with severe aortic stenosis and we are excited to enroll our first patients into this rigorous study.”