U.S. — One-year clinical outcomes from the U.S. early feasibility study of the J-Valve Transfemoral System for severe aortic regurgitation were published on June 25, 2026, in the Journal of the Society for Cardiovascular Angiography & Interventions. The study, titled "Transcatheter Aortic Valve Replacement in Patients with Symptomatic, Severe Aortic Regurgitation: One-Year Outcomes of the J-Valve Transfemoral Early Feasibility Study," evaluated the safety and effectiveness of the transfemoral J-Valve transcatheter heart valve system in patients with severe native aortic regurgitation who were deemed high risk for surgical aortic valve replacement.

This prospective, single-arm, multicenter early feasibility study enrolled 25 patients across eight U.S. centers. Participants had a mean age of 80.6 years. All individuals had symptomatic severe native aortic regurgitation and were deemed high risk for surgical aortic valve replacement by a local multidisciplinary Heart Team. Successful valve implantation occurred in 92% of the patients.

The study's primary endpoint, a composite of all-cause mortality or disabling stroke at 30 days, was observed in two patients, representing 8.0% of the cohort. All-cause mortality was 4.0% at both 30 days and one year. No cardiovascular-related deaths occurred at either 30 days or one year.

At the one-year mark, New York Heart Association functional class improved in 72.7% of patients. Additionally, 95.5% of patients were classified as New York Heart Association Class I or II. Reverse left ventricular remodeling was evident at 30 days and maintained through one year. Dean J. Kereiakes, Chair of The Christ Hospital Heart and Vascular Institute, stated, "While larger studies are needed, these data support continued evaluation of the J-Valve system as a potential option for patients with severe AR and limited alternatives."

The study plans for continued follow-up through five years. The J-Valve trial received funding from JC Medical, Inc., an affiliate of Edwards Lifesciences LLC.