Study of the J-Valve Transfemoral System to Treat Severe Aortic Valve Regurgitation in High-Risk Patients

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the J-Valve Transfemoral TF System in adults with symptomatic, severe native aortic valve regurgitation AR or AR-dominant mixed aortic valve disease. The study focuses on patients considered high risk for traditional open surgical aortic valve replacement. A sub-study using Cardiac Magnetic Resonance CMR imaging will explore how treating AR affects heart muscle remodeling, clinical outcomes, quality of life, and differences between genders. This is a prospective, single-arm, multi-center interventional study enrolling up to 194 participants across up to 35 sites in the United States, Canada, Europe, and Japan. Treatment involves using the J-Valve TF System, a transcatheter aortic valve replacement device delivered via a catheter through the femoral artery. Up to 40 initial roll-in subjects may be treated to gain experience with the device. Participants will be followed for five years after the procedure. Participants will undergo detailed assessments including imaging tests like transthoracic and transesophageal echocardiography, and CMR scans for the sub-study. Researchers will track outcomes such as survival at one year, early safety events within 30 days, and improvements in heart function and health status over one year. Follow-up visits and evaluations will continue throughout the five-year post-procedure period to monitor long-term safety and effectiveness.

J-Valve Transfemoral Pivotal Study