J-Valve study reports encouraging one-year results in severe aortic regurgitation
An early feasibility study found the investigational transfemoral valve had sustained performance in high-risk patients with severe native aortic regurgitation.
By Tom Brennan · Health & Medicine Correspondent
2 min read
An investigational transcatheter heart valve system showed encouraging one-year outcomes in a small study of patients with symptomatic severe aortic regurgitation who faced high risk from surgery. The findings matter because surgical valve replacement remains the recommended treatment for many patients, but older adults and patients with complex health risks can have few alternatives.
The results were published in JSCAI and presented at New York Valves 2026, according to the Society for Cardiovascular Angiography and Interventions. The study evaluated the J-Valve Transfemoral System, a transcatheter aortic valve replacement device designed for severe native aortic regurgitation.
Aortic regurgitation occurs when the aortic valve fails to seal properly, allowing blood to flow backward into the heart. The study focused on patients whose condition was symptomatic and severe, and who were judged by local multidisciplinary Heart Teams to be at high risk for surgical aortic valve replacement.
The prospective, single-arm, multicenter early feasibility study enrolled 25 patients at eight U.S. sites, according to the investigators. Participants had a mean age of 80.6 years.
Valve implantation was successful in 92% of patients, the study reported. The primary endpoint, a combined measure of death from any cause or disabling stroke at 30 days, occurred in two patients, or 8.0%.
All-cause mortality was 4.0% at 30 days and remained 4.0% at one year, according to the study. Investigators reported no cardiovascular-related deaths.
Patients also showed signs of sustained clinical improvement. At one year, 72.7% had improved New York Heart Association functional class, and 95.5% were in Class I or II, the investigators reported.
The study also found evidence of reverse left ventricular remodeling by 30 days, with that finding sustained through one year. Reverse remodeling refers to favorable changes in the size or function of the heart’s left ventricle after treatment.
Dean J. Kereiakes, first author of the study and chair of the Christ Hospital Heart and Vascular Institute in Cincinnati, said severe native aortic regurgitation has been difficult to treat with transcatheter approaches. He said the early feasibility results were encouraging because the device is dedicated to aortic regurgitation and showed sustained valve performance, symptom improvement and evidence of reverse left ventricular remodeling at one year.
Kereiakes also said larger studies are needed, and that the data support continued evaluation of the J-Valve system for patients with severe aortic regurgitation and limited alternatives.
The investigators plan to follow patients for five years. More definitive evidence is expected from JOURNEY, a larger ongoing trial of the system, according to the Society for Cardiovascular Angiography and Interventions.
This story draws on original reporting from Medical Xpress.