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Trial of next-generation TAVR system underway

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The first patients have been enrolled in the Evolut R FORWARD Clinical Study, which will evaluate performance outcomes using the CoreValve Evolut R transcatheter aortic valve replacement system in everyday clinical practice.

Evolut R FORWARD is a multicenter, single-arm, prospective study of up to 1,000 high- and extreme-risk patients at 60 centers worldwide. The primary endpoint is all-cause mortality at 30 days post-implant in patients with severe symptomatic aortic valve stenosis. Secondary endpoints will include VARC-2 safety and efficacy, according to a company press release.

The study is designed to develop rigorous evidence through thorough monitoring at all centers, leveraging independent safety review and core-lab adjudicated hemodynamic performance. Follow-up will be conducted at implant, 30 days, 1 year, 2 years and 3 years, according to the release.

The first patients in this study were enrolled at University Hospital in Bonn, Germany, by Georg Nickenig, MD, PhD, and fellow investigators.

“Evolut R has demonstrated some of the most promising clinical results of any [TAVR] valve in its premarket trial,” Eberhard Grube, MD, director of the Structural Heart Program at University Hospital in Bonn, Germany, and co-principal investigator, stated in the release. “We are excited to enroll our patients into this rigorous study to show that the same results can be delivered in a real-world clinical setting.”

Previously reported 1-year results of the Evolut R CE Study demonstrated a low rate of stroke (3.4%), strong hemodynamic performance, low moderate/severe paravalvular leak (4.3%) and low rate of pacemaker implantation (15.2%) in patients with high- and extreme-risk aortic stenosis, according to the release.

The recapturable, repositionable, self-expanding TAVR system was approved by the FDA in June 2015 for treatment of patients with severe aortic stenosis who are at high or extreme risk for surgery.