The CoreValve Evolut R trial is designed to evaluate the CoreValve Evolut R device, which the Fridley, Minn.-based medical device company designed to allow physicians to retrieve and reposition the valve during implantation, according to a press release.
The system includes the CoreValve Evolut R device and Medtronic’s EnVeo R "recapturable" delivery system, according to the release. The EnVeo R includes a new, smaller-profile sheath called the InLine, Medtronic said.
"CoreValve has set a high bar for rates of procedural success, which have been confirmed in both real-world use and clinical studies such as CoreValve Advance. We are studying this recapture-enabled valve and low profile delivery system to provide design enhancements that further increase procedural confidence and, ultimately, improve patient care," principal investigator Dr. Ian Meredith of Monash Medical Centre – Southern Health in Melbourne, Australia, said in prepared remarks
The 60-patient study will enroll subjects with severe symptomatic aortic stenosis for whom open heart valve replacement surgery is too risky, Medtronic said. The primary endpoints are all-cause mortality and stroke at 30 days and device success rate at 24 hours to 7 days. Secondary endpoints include recapture success rate, when attempted, and hemodynamic performance, according to the release.