Medtronic has announced that the FDA has approved an expanded indication trial for the CoreValve Evolut R System, which enables the transcatheter aortic valve implantation (TAVI) device to be investigated in patients with aortic stenosis who are at a low surgical mortality risk as determined by a heart team. Enrolment for the investigational device exemption (IDE) trial is expected to begin this spring and will include 1,200 patients with severe aortic stenosis who have a less than 3% risk of mortality
A press release reports that the trial will enrol low-risk patients from up to 80 clinical sites with 1:1 randomisation to receive the Evolut R system or undergo surgical aortic valve replacement. The IDE trial is designed as an adaptive trial with a primary endpoint of all-cause mortality or disabling stroke. The trial has a two-year endpoint and allows for a one-year analysis for early FDA submission. Additionally, the trial will include a substudy of leaflet mobility in 400 patients.
According to the press release, Evolut R is optimised to increase conformability and sealing at the annulus, while maintaining supra-annular valve positioning for improved blood flow and haemodynamic performance. The valve is delivered through the EnVeo R delivery catheter system, which features an InLine sheath that provides the lowest profile on the market (14 Fr equivalent, less than 1/5 inch). The low profile enables treatment of patients with vessels down to 5mm through the preferred transfemoral access route, and may minimise the risk of major vascular complications in some patients.
Michael Reardon (professor of cardiothoracic surgery, Houston Methodist DeBakey Heart & Vascular Center, Houston, USA), the principal investigator of the IDE study, says: “This trial comes on the heels of data showing patients who underwent TAVI with this self-expanding platform demonstrated superior survival benefit—with low and stable stroke rates—compared with surgical patients. It is an important next step in developing robust clinical evidence to help heart teams understand the potential benefits of TAVI in a broader patient population.”