FORWARD Clinical Study Begins for Medtronic's Evolut R TAVR System in Real-World Setting

March 7, 2016—Medtronic plc announced that Prof. Georg Nickenig, MD, enrolled the first patients in the Evolut R FORWARD clinical study at University Hospital in Bonn, Germany.

The global, multicenter, single-arm, prospective FORWARD study will evaluate performance outcomes using the company’s next-generation CoreValve Evolut R recapturable and repositionable transcatheter aortic valve replacement (TAVR) system. Up to 1,000 high-risk and extreme-risk patients will be enrolled in at least 60 centers worldwide and will document the clinical and device performance outcomes of the Evolut R system used in routine clinical practice. The study will be conducted at centers in Europe, Australia, the Middle East, Africa, Latin America, and Canada.

According to Medtronic, the primary endpoint will evaluate all-cause mortality at 30-days postimplant in patients with severe symptomatic aortic valve stenosis. Secondary endpoints will include VARC-2 safety and efficacy. The study is designed to develop rigorous evidence through complete monitoring at all centers, leveraging independent safety review and core lab–adjudicated hemodynamic performance. The device will be evaluated at implant with follow-up conducted at 30 days, 1 year, 2 years, and 3 years after implantation.

Professor Eberhard Grube, MD, Director of the Structural Heart Program at University Hospital in Bonn, Germany, serves as Coprincipal Investigator of the FORWARD study. 

In the company’s press release, Prof. Grube commented, “Evolut R has demonstrated some of the most promising clinical results of any TAVR valve in its premarket trial, and 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.”

Medtronic stated that the data from the Evolut R CE study have shown the highest reported survival rate (93.3%) for high-risk and extreme-risk aortic stenosis patients at 1-year follow-up. The Evolut R CE study was presented by study investigator Ganesh Manoharan, MD, in October at TCT 2015, the 27th annual Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco, California.

Data from the Evolut R CE study that evaluated high-risk and extreme-risk patients with aortic stenosis reported a low 1-year stroke rate at 3.4%, strong hemodynamic performance (single-digit gradients at 1 year), low rates of moderate or severe paravalvular leak (4.3% at 1 year), and a low pacemaker implantation rate (15.2% at 1 year).

The CoreValve Evolut R is available in Europe and other countries that recognize the CE Mark and was approved for commercial use in the United States in 2015.