PinnacleHealth (East Cowes, USA) has enrolled the first patient nationally in a new clinical trial investigating a larger size of the Medtronic CoreValve Evolut R system—the Evolut R 34mm system.
The larger transcatheter aortic valve replacement (TAVR) technology is designed to treat severe aortic stenosis patients with a larger annulus—specifically those with an annulus diameter between 26-30mm. Annulus sizes vary between individuals.
The new trial for the Evolut R 34mm system at PinnacleHealth is led by Mubashir, chief of cardiothoracic surgery and surgical director of structural heart, and Hemal Gada, medical director of structural heart.
“Participating in this trial allows us to offer TAVR to a subset of patients who formerly had limited treatment options,” says Mumtaz.
The Medtronic Evolut34R US clinical study is a prospective, single-arm study that will include 60 patients at up to 15 clinical sites. The study is designed to confirm the safety and efficacy of the CoreValve Evolut R 34mm system, and to compare the results to the Evolut R IDE. The prospective study will have a primary safety endpoint of all-cause mortality or disabling stroke at 30 days and primary efficacy endpoints of
device success and total regurgitation at 30 days.
The Medtronic Evolut R 34mm system builds off of the CoreValve Evolut R transcatheter valve, which was US Food and Drug Administration-approved for commercial use in the USA in June 2015 for severe aortic stenosis patients who are at high or extreme risk for surgery.