Medtronic has announced a new study to evaluate its next-generation transcatheter aortic valve replacement (TAVR) system in everyday clinical practice. The self-expanding CoreValve Evolut PRO valve was recently approved for commercial use in Europe and the United States.
According to a press release, the valve contains a biocompatible porcine pericardial tissue wrap designed to prevent leakage. In a previous study of 60 patients, the Evolut PRO demonstrated low rates of mortality and disabling stroke (1.7 percent for both) through 30 days. There were no incidents of moderate or severe paravalvular leak.
The new study will enroll 600 patients across 35 sites in Europe and evaluate all-cause mortality and stroke at 30 days, in addition to valve hemodynamics and paravalvular regurgitation. Patients will be followed for up to five years.
"We look forward to replicating the excellent clinical outcomes demonstrated by the Evolut PRO valve in a study designed to look at the valve's longer-term real-world performance," Eberhard Grube, MD, director of the Structural Heart Program at University Hospital in Bonn, Germany, and co-principal investigator of the study, said in the release. "The Evolut PRO has shown exceptional results for patients with severe aortic stenosis and we are excited to enroll our first patients into this rigorous study."