TRanscAtheter TreatMent of PurE Aortic Regurgitation With VitaFlow Liberty System

This study is a prospective, multicenter, non-randomized controlled trial, planning to enroll 180 patients with pure native aortic regurgitation. On the basis of standardized medical therapy, patients will be assigned in a 1:1 ratio to undergo transfemoral transcatheter aortic valve replacement (TF-TAVR) . This prospective, multicenter trial aims to evaluate the safety and effectiveness of transfemoral TAVR using the VitaFlow™ self-expanding valve system compared to dedicated transcatheter devices in patients with PNAR. The primary endpoint is a composite of all-cause mortality, disabling stroke, and rehospitalization for heart failure, myocardial Infarction, and requiring dialysis or valve reoperation at 12 months post-procedure. Secondary endpoints include procedure-related complications, long-term clinical events, patient functional status and quality of life, bioprosthetic valve imaging follow-up, echocardiographic parameters, and treatment costs. All endpoint definitions conform to the Valve Academic Research Consortium-3 (VARC-3) criteria

NCT Number	NCT06818084
Lead Sponsor	Ruijin Hospital
Conditions	AORTIC VALVE DISEASES, Aortic Regurgitation, Transcatheter Aortic Valve Replacement (TAVR)
Enrollment	120 participants
Start Date	2025-04-29
Primary Completion	2027-11-30 (estimated)
Study Completion	2027-11-30 (estimated)
Updated on ClinicalTrials.gov	2026-01-30