Actively Recruiting
TRanscAtheter TreatMent of PurE Aortic Regurgitation With VitaFlow Liberty System
Led by Ruijin Hospital · Updated on 2026-01-30
120
Participants Needed
4
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
TRanscAtheter TreatMent of PurE Aortic Regurgitation With VitaFlow Liberty System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60 years or older
- Symptomatic moderate-to-severe or greater isolated aortic regurgitation
- Asymptomatic moderate-to-severe or greater isolated aortic regurgitation with at least one of the following: LVEF ≤ 55% by biplane Simpson's method, LVESD > 50 mm, LVESDi > 22 mm/m², or LVESVi > 45 mL/m²
- Anatomical suitability for transcatheter aortic valve replacement as assessed by the heart team
- Provision of written informed consent and willingness to comply with all required follow-up assessments
You will not qualify if you...
- Incomplete coronary revascularization
- Less than 30 days of guideline-directed medical therapy at maximally tolerated doses
- Life expectancy less than 1 year
- Left ventricular ejection fraction less than 45%
- Estimated glomerular filtration rate less than 30 mL/min/1.73m²
- Known allergy or contraindication to required medications (aspirin, clopidogrel, warfarin) or contrast media
- Any condition that prevents contrast-enhanced CT
- Concurrent moderate-to-severe or severe valvular heart disease other than aortic regurgitation
- Poor patient compliance or inability to complete required follow-up
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Ruijin hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
2
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
3
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
4
Changhai Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
Research Team
Z
Zhengbin Zhu, MD. PhD.
CONTACT
J
Jiwei Yu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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