Evaluating VitaFlow and J-Valve Systems for Treating Aortic Valve Leakage in Adults 60 and Older

What this Trial Is About

This research aims to evaluate the safety and effectiveness of transfemoral transcatheter aortic valve replacement TF-TAVR using the VitaFlow self-expanding valve system compared to other dedicated transcatheter devices in patients with pure native aortic regurgitation. The study will enroll 180 patients with symptomatic or asymptomatic moderate-to-severe isolated aortic regurgitation who are 60 years or older, assessing major clinical outcomes over 12 months. The trial follows Valve Academic Research Consortium-3 VARC-3 criteria for endpoint definitions. Participants will be assigned in a 11 ratio to receive TF-TAVR using either the VitaFlow valve system or the J-Valve system, both combined with guideline-directed medical therapy. The VitaFlow system features a self-expanding nitinol frame with a bovine pericardial valve and a double-layer skirt designed to reduce leaks. The J-Valve system includes a porcine bioprosthetic valve with nitinol graspers for positioning. The study compares clinical events, valve imaging, functional status, quality of life, and costs between these two interventions. During the study, participants will have assessments at baseline, 6 months, and 12 months, including echocardiography to evaluate heart function and valve performance, computed tomography angiography to assess valve leaflet motion, and questionnaires measuring heart failure symptoms, social support, physical activity, and walking ability. Researchers will monitor for complications, hospitalizations, mortality, and treatment expenses over the 12-month period to evaluate the overall clinical impact and safety of the procedures.

TRanscAtheter TreatMent of PurE Aortic Regurgitation With VitaFlow Liberty System