Medtronic launches real-world trial for CoreValve Evolut R heart valve

Medtronic (NYSE:MDT) said today that it’s launching a real-world trial of its CoreValve Evolut R transcatheter aortic valve implant in high- and extreme-risk patients.

The 1,000-patient Evolut R Forward trial is a single-arm, prospective study with a primary endpoint of all-cause mortality at 30 days, with secondary endpoints of Valve Academic Research Consortium-2 safety and efficacy. The study is designed for follow-up at implant, 30 days, 1 year, 2 years and 3 years, Fridley, Minn.-based Medtronic said.

“Evolut R has demonstrated some of the most promising clinical results of any TAVI valve in its pre-market trial, and we are excited to enroll our patients into this rigorous study to show that the same results can be delivered in a real world clinical setting,” co-principal investigator Dr. Eberhard Grube, of the University Hospital in Bonn, Germany, said in prepared remarks.

Last month Medtronic won FDA approval for a clinical trial of the CoreValve Evolut R in patients at low risk from open heart surgery.

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