NCT06818084

TRanscAtheter TreatMent of PurE Aortic Regurgitation With VitaFlow Liberty System

Transcatheter Treatment of Pure Aortic Regurgitation With VitaFlow Liberty System: a Prospective, Multicenter Study

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The purpose of this study is to evaluate the safety and efficacy of TF-TAVR for the treatment of isolated aortic regurgitation. The study will compare all-cause mortality, cardiovascular mortality, stroke, rehospitalization for heart failure, and renal failure requiring dialysis treatment at 12 months after TAVR. Additionally, the study will assess the incidence of hypoattenuated leaflet thickening (HALT) and reduced leaflet motion (RLM) via CTA, as well as the aortic valve root-prosthesis coaxiality. Changes and differences between groups in the following parameters will be evaluated using transthoracic echocardiography at 6 and 12 months after enrollment: left ventricular ejection fraction (Simpson method), left ventricular end-diastolic volume index (LVEDVi), left ventricular end-systolic volume index (LVESVi), left ventricular end-diastolic diameter (LVEDd), left ventricular end-systolic diameter (LVESd), estimated aortic valve orifice area, valvular regurgitation, and transvalvular pressure gradient compared with baseline. The study will also compare changes and differences between groups in the Minnesota Living with Heart Failure Questionnaire, Social Support Rating Scale (SSRS), International Physical Activity Questionnaire (IPAQ), and 6-minute walk test (6MWT) at 6 and 12 months after enrollment compared with baseline. Furthermore, the study will compare surgical costs, potential complication costs, and disease-related costs between the two groups.

Conditions

• AORTIC VALVE DISEASES
• Aortic Regurgitation
• Transcatheter Aortic Valve Replacement (TAVR)

Interventions

Type	Name	Description
COMBINATION_PRODUCT	VitaFlow+GDMT	The patient will undergo transcatheter aortic valve replacement on the basis of guideline-directed medical therapy with The VitaFlow™ system. The VitaFlow™ system (MicroPort®, Shanghai, China) was a novel TAVR system, which incorporates high-radial force and a double layer polyethylene terephthalate (PET) skirt to optimize frame geometry and minimize the risks of paravalvular leak (PVL). The VitaFlow™ transcatheter aortic valve is made of a self-expanding nitinol frame and tri-leaflet bovine pericardial valve.
COMBINATION_PRODUCT	J-Valve+GDMT	The patient will undergo transfemoral aortic valve replacement on the basis of guideline-directed medical therapy with The J-Valve system (Jie ChengMedical Technologies, Suzhou, China). The J-Valve system is a second-generation self-expand able device composed of a porcine bioprosthetic aortic valve and a transfemoral delivery sheath. The valve is supported by a self-expanding nitinol structure. The different valve sizes are 21, 23, 25, 27, 29 and 34 mm. Three U-shaped nitinol graspers were designed to surround the valve.

Timeline

• Start date: 2025-04-29
• Primary completion: 2027-11-30
• Completion: 2027-11-30
• First posted: 2025-02-10
• Last updated: 2026-01-30

Locations

4 sites across 1 country: China