A new post-market clinical study is to evaluate Medtronic’s CoreValve Evolut Pro transcatheter aortic valve implantation (TAVI) valve in everyday clinical practice. Studying patients with severe symptomatic aortic stenosis at an intermediate, high or extreme risk for open heart surgery, the FORWARD PRO clinical study will evaluate longer term performance (out to five years) of the next-generation self-expanding TAVI system.
A press release reports that the multicentre, prospective single-arm study will enrol 600 patients across 35 sites in Europe, and will evaluate safety including all-cause mortality and all stroke at 30 days and clinical performance including valve haemodynamics and paravalvular regurgitation. Patients will be followed out to five years.
Eberhard Grube (University Hospital, Bonn, Germany), co-principal investigator of the FORWARD PRO study, says: “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. The Evolut Pro has shown exceptional results for patients with severe aortic stenosis and we are excited to enrol our first patients into this rigorous study.”
The Evolut Pro valve—built off the Evolut R platform—is designed with an outer tissue wrap to further advance valve sealing performance. The press release says that the biocompatible porcine pericardial tissue wrap, in addition to other design elements, is incorporated to address the occurrence of blood leaking through the sides of the valve.