Medtronic announced on March 31 that the first patients had enrolled in an expanded indication trial for the CoreValve Evolut R System, a device for transcatheter aortic valve replacement (TAVR) procedures.
The FDA approved the CoreValve Evolut R System in June 2015 to treat patients with severe aortic stenosis.
The first patients for the expanded indication trial enrolled at PinnacleHealth CardioVascular Institute in Harrisburg, Penn. They were treated by chief of cardiothoracic surgery Mubashir Mumtaz, MD, medical director of structural heart Hemal Gada, MD, MBA, and the rest of the institute’s heart team.
The trial is expected to enroll 1,200 patients with severe aortic stenosis and less than three percent risk of operative mortality at up to 80 centers. The researchers will randomize patients in a 1:1 ratio to receive TAVR with the CoreValve Evolut R System or undergo surgical aortic valve replacement.
The primary endpoint will by all-cause mortality or disabling stroke at two years, although the researchers will analyze results after a year and possibly submit the early data to the FDA, according to a news release. The trial will also included a sub-study evaluating leaflet mobility in 400 patients.