Medtronic plc says the first patients have been enrolled in its Evolut™R FORWARD Clinical Study, a global, multi-center, single-arm, prospective study of up to 1,000 patients, to evaluate performance outcomes using the CoreValve™ Evolut R System in everyday clinical practice.
Evolut R is a next-generation, recapturable and repositionable transcatheter aortic valve implantation (TAVI) system. Data from the Evolut R CE Study that was recently presented at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium has shown the highest reported survival rate (93.3 percent) for high and extreme risk aortic stenosis patients at one-year follow-up.
Built on the proven foundation and procedural success of the CoreValve System, which has been implanted in more than 100,000 patients in 60 countries, 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. Geographies participating in the study include centers in Europe, Australia, the Middle East, Africa, Latin America and Canada.
Data from the Evolut R CE Study, which evaluated high- and extreme-risk patients with aortic stenosis, reported a low, one-year stroke rate at 3.4 percent, strong hemodynamic performance (single-digit gradients at one year), low rates of moderate or severe paravalvular leak (4.3 percent at one year), and low pacemaker implantation rate (15.2 percent one year).
The new study will enroll high- and extreme-risk patients 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 primary endpoint will evaluate 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. The study is designed to develop rigorous evidence through complete monitoring at all centers, leveraging independent safety review and core-lab adjudicated hemodynamic performance. Follow-up will be conducted at implant, 30-days, one-year, two-years and three-years post-implant.
The first patients in the study were enrolled at University Hospital in Bonn, Germany, by the team of Prof. Georg Nickenig.
“Evolut R has demonstrated some of the most promising clinical results of any TAVI valve in its pre-market 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,” said Prof. Eberhard Grube, M.D., director of the Structural Heart Program at University Hospital in Bonn, Germany, and co-principal investigator of the FORWARD Study.
Source: Medtronic, PLC