Medtronic enrolls first patients in CoreValve Evolut R trial for expanded FDA indication
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.
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.