The 1,200-patient trial is designed for patients with less than 3% risk of dying from open valve surgery, randomized to either transcatheter aortic valve replacement with the CoreValve device or surgical aortic valve replacement. It’s the 3rd trial for Medtronic’s TAVR offering since February, when the FDA approved the new investigational device exemption study.
The primary endpoint is all-cause mortality or disabling stroke at 2 years, the company said. The study includes a 400-patient subgroup to study leaflet mobility, possibly the cause of a higher risk for blood clot and stroke. Medtronic said it can also submit a 1-year analysis to the FDA for an early review.
The 1st patients were enrolled by Dr. Mubashir Mumtaz and Hemal Gada of Harrisburg, Pa.’s PinnacleHealth CardioVascular Institute, the company said.
“Our team of cardiologists and cardiovascular surgeons is pleased to be involved in this next phase of clinical investigation,” Mumtaz said in prepared remarks. “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.”
Earlier this month, Medtronic announced a 1,000-patient real-world trial of the CoreValve Evolut R in high- and extreme-risk patients. In February, the company won FDA approval for a trial of the device in low-risk cohort.