Medtronic announced on March 7 that the first patients had enrolled in a clinical trial to test the performance of the CoreValve Evolut R system in a real world setting.
The patients were enrolled at University Hospital in Bonn, Germany. The multicenter, single-arm, prospective Evolut R FORWARD study will enroll up to 1,000 high- to extreme-risk patients in at least 60 center in Europe, Australia, the Middle East, Africa, Latin America and Canada.
The FDA approved the CoreValve Evolut R in June to treat patients with severe aortic stenosis undergoing transcatheter aortic valve replacement.
The Evolut R FORWARD trial’s primary endpoint is all-cause mortality at 30 days post-implant in patients with severe symptomatic aortic valve stenosis, while second endpoints include Valve Academic Research Consortium-2 safety and efficacy.
The researchers plan on following up with patients at implant, 30 days, one year, two years and three years after implantation.