TRanscAtheter TreatMent of PurE Aortic Regurgitation With VitaFlow Liberty System
Recruiting now · Phase 4
Conditions studied: AORTIC VALVE DISEASES, Aortic Regurgitation, Transcatheter Aortic Valve Replacement (TAVR)
In brief
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
Key facts
- Study ID
- NCT06818084
- Run by
- Ruijin Hospital
- People needed
- 120
- Starts
- 2025-04-29
- Expected to finish
- 2027-11-30
- Last updated by the study team
- 2026-01-30
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Ruijin hospital, Shanghai JiaoTong University School of Medicine — Shanghai, Shanghai Municipality, China (enrolling)
- Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (enrolling)
- Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (enrolling)
- Changhai Hospital — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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