New research published on June 25 in JSCAI and presented at New York Valves 2026 reported favorable one-year outcomes for patients with symptomatic severe aortic regurgitation treated with the investigational J-Valve Transfemoral System.
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," assessed the safety and effectiveness of the transfemoral J-Valve transcatheter heart valve system. The study focused on patients with severe native aortic regurgitation who were considered high risk for surgical aortic valve replacement.
Aortic regurgitation is a condition where the aortic valve does not close properly, causing blood to leak backward into the heart. While surgical aortic valve replacement is typically recommended for many patients with severe disease, options are limited for those who are older or have complicating factors that increase surgical risk.
The prospective, single-arm, multicenter early feasibility study enrolled 25 patients at eight centers across the United States. The participants had an average age of 80.6 years; all had symptomatic severe native aortic regurgitation and were determined by local multidisciplinary Heart Teams to be high risk for surgery. Successful implantation of the J-Valve occurred in 92% of cases. The primary endpoint—a composite measure of all-cause mortality or disabling stroke at 30 days—was observed in two patients (8%). All-cause mortality was reported as 4% at both 30 days and one year, with no cardiovascular-related deaths during this period.
Patients demonstrated sustained improvements in symptoms and overall health status following treatment. At one year after implantation, New York Heart Association functional class improved in nearly three-quarters (72.7%) of participants, and 95.5% were classified as Class I or II regarding symptom severity. Evidence also showed reverse left ventricular remodeling at 30 days that persisted through one year.
Continued follow-up is planned through five years to monitor long-term outcomes, while more comprehensive data will be provided by the larger ongoing JOURNEY trial evaluating this device further. The J-Valve trial received funding from JC Medical, Inc., an affiliate of Edwards Lifesciences LLC.
