US-based healthcare service provider PinnacleHealth System has enrolled the first patient for a new clinical trial to evaluate the Evolut R 34mm system to treat severe aortic stenosis patients with a larger base of the aortic root.
Around 60 patients at up to 15 clinical sites will be enrolled in the prospective, single-arm Medtronic Evolut 34R US Clinical Study.
The trial will be led by structural heart surgical director and cardiothoracic surgery chief Mubashir Mumtaz and structural heart medical director Hemal Gada.
It is designed to assess the safety and efficacy of the CoreValve Evolut R 34mm System, as well as compare it to that of Evolut R IDE.
The trial focuses on the primary endpoint to reduce the all-cause mortality or disabling stroke after 30 days, while its primary efficacy endpoints focus on demonstrating the device success and total regurgitation at 30 days.
The Evolut R 34mm System is a larger version of Medtronic CoreValv Evolut R System, which features a larger transcatheter aortic valve replacement (TAVR) technology, which allows physicians to leverage on advanced imaging technology to model the anatomy of the heart, measure the annulus and select the appropriate valve size.
Aortic stenosis is characterised by a narrowing heart's aortic valve due to excessive calcium deposition on the valve leaflets.
A narrowed valve makes the heart work harder to pump blood throughout the body resulting to a weakening and a poorly functioning heart which eventually increases the risk of heart failure or a sudden cardiac death.
The CoreValve Evolut R 34mm Valve involves a minimally invasive procedure to replace a diseased aortic heart valve.
It is inserted through an artery in the leg and then guided through the arteries into the heart.
After being placed, it assumes the original valve's function to allow oxygen-rich blood flow out of the heart.
Image: PinnacleHealth System to evaluate Medtronic CoreValv Evolut R System. Photo: courtesy of PinnacleHealth System.