Enrollment Begins in Trial of Medtronic's CoreValve Evolut R TAVR System in Low-Risk Patients

March 31, 2016—Medtronic plc announced that the first patients were enrolled in the expanded indication trial for the CoreValve Evolut R system, the company’s next-generation, recapturable, self-expanding transcatheter aortic valve replacement (TAVR) system. The first patients were enrolled at PinnacleHealth CardioVascular Institute in Harrisburg, Pennsylvania, by the heart team led by Mubashir Mumtaz, MD, Chief of Cardiothoracic Surgery, and Hemal Gada, MD, Medical Director of Structural Heart at PinnacleHealth.

In Medtronic’s announcement, Dr. Mumtaz commented, “Our team of cardiologists and cardiovascular surgeons is pleased to be involved in this next phase of clinical investigation. It is invigorating to be on the national forefront of care and to help heart teams understand the potential benefits of TAVR in a broader patient population.”

On February 22, Medtronic announced US Food and Drug Administration (FDA) approval for the trial.

According to Medtronic, this clinical trial will include 1,200 patients with severe aortic stenosis who have a < 3% risk of operative mortality, as determined by a heart team. The trial will enroll low-risk patients at up to 80 clinical sites with 1:1 randomization to receive the Evolut R system or to undergo surgical aortic valve replacement.

The investigational device exemption is designed as an adaptive trial with a primary endpoint of all-cause mortality or disabling stroke. The trial has a 2-year endpoint and allows for a 1-year analysis for early FDA submission. Additionally, the trial will include a substudy of leaflet mobility in 400 patients.

In June 2015, the CoreValve Evolut R transcatheter valve and the CoreValve EnVeo R delivery catheter system were FDA approved for commercial use in the United States. They also have European CE Mark approval and are commercially available in Europe and other countries that recognize the CE Mark.