Medtronic announces real world study of the CoreValve Evolut R system
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.
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.