FORWARD PRO Postmarket Study Will Evaluate Medtronic's CoreValve Evolut Pro TAVR System
September 21, 2017—Medtronic announced a new postmarket clinical study that will evaluate its CoreValve Evolut Pro transcatheter aortic valve replacement (TAVR) system in everyday clinical practice, including patients with severe symptomatic aortic stenosis at an intermediate, high, or extreme risk for open heart surgery.
The FORWARD PRO clinical study will evaluate the longer-term performance of the company's next-generation, self-expanding TAVR system, which was recently approved for commercial use in Europe and the United States.
The multicenter, prospective, single-arm FORWARD PRO study will enroll 600 patients across 35 sites in Europe. The study will evaluate safety including all-cause mortality and all stroke at 30 days, as well as clinical performance including valve hemodynamics and paravalvular regurgitation. Patients will be followed out to 5 years.
The Evolut Pro valve is built from Medtronic's Evolut R platform and is designed with an outer tissue wrap to further advance valve sealing performance. The biocompatible porcine pericardial tissue wrap, in addition to other design elements, is incorporated to address the occurrence valvular leak.
The company noted that the Evolut Pro valve showed no moderate/severe paravalvular leak (0%), high rates of survival (98.3%), and a low rate of disabling stroke (1.7%) at 30 days in data presented in March at ACC.17, the American College of Cardiology's 66th annual scientific session in Washington, DC.
Prof. Eberhard Grube, MD, Coprincipal Investigator of the FORWARD PRO study, commented in Medtronic's announcement, “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 enroll our first patients into this rigorous study.”