Medtronic has announced the first US implants in the CoreValve Evolut R Clinical Study, which will evaluate the safety and effectiveness of the new Medtronic CoreValve Evolut R system. This novel investigational self-expanding valve and 14F equivalent delivery system offer new capabilities that are designed to advance deliverability and valve performance while providing the option to recapture and reposition the CoreValve Evolut R valve during deployment, if needed, while performing transcatheter aortic valve implantation (TAVI).
“In clinical trials and real-world use, patients treated with the current CoreValve System have experienced high rates of survival, low rates of stroke and improved quality of life. This study will build on that strong legacy by evaluating the next generation of this successful system, a recapture-enabled valve with the lowest-profile delivery system,” says Mathew Williams, co-primary investigator for the study, and chief of Adult Cardiac Surgery and director of Interventional Cardiology and Structural Heart at NYU Langone Medical Center in New York City, USA.
The prospective CoreValve Evolut R clinical study will enrol up to 250 patients with severe symptomatic aortic stenosis who are considered at high or extreme risk for open-heart surgical aortic valve replacement, at up to 25 US sites. The primary endpoints are all-cause mortality and disabling stroke at 30 days, as well as device success rate at 24 hours to seven days.
Secondary endpoints include recapture success rate, when attempted, and haemodynamic performance.
The new system consists of the CoreValve Evolut R transcatheter valve and the EnVeo R delivery system. The new valve is anatomically designed to increase conformability at the annulus for optimal annular fit and sealing, while maintaining supra-annular valve position for improved blood flow and haemodynamic performance. The EnVeo R delivery system offers a new InLine Sheath which significantly reduces the profile of the catheter shaft to 14 F equivalent (less than 1/5 inch). The EnVeo system’s 1:1 delivery response is designed to provide first-time valve placement accuracy during deployment. The new system builds on experience from more than 65,000 CoreValve System implants worldwide.
“The Evolut R system is designed to provide physicians with greater confidence throughout the procedure, and a back-up plan in case the valve is not positioned correctly at first,” says Jeffrey J Popma, director of Interventional Cardiology at the Beth Israel Deaconess Medical Center and professor of medicine at Harvard Medical School, Boston, USA, who served as national co-principal investigator of the original CoreValve US Pivotal Trial. “While the delivery system is designed to enable accurate positioning on the first attempt, the added assurance of recapturability to a commercially proven valve will be a significant advance for TAVI therapy.”
The CoreValve Evolut R transcatheter valve system received CE mark earlier this month. In the US, the CoreValve Evolut R system is limited to investigational use only.