TRanscAtheter TreatMent of PurE Aortic Regurgitation With VitaFlow Liberty System

NCT06818084 · tracked via the Priya Life Science China tracker

Sponsor

Ruijin Hospital

Phase

Phase 4

Started

2025-04-29

Last updated

2026-01-30

Condition(s) studied

AORTIC VALVE DISEASESAortic RegurgitationTranscatheter Aortic Valve Replacement (TAVR)

Investigational drug(s) / intervention(s)

VitaFlow+GDMTJ-Valve+GDMT

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.

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.

Study 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

Eligibility

Sex

ALL

Min age

60 Years

Max age

—

Healthy volunteers

Inclusion Criteria Age ≥ 60 years. Symptomatic moderate-to-severe or greater isolated aortic regurgitation. Asymptomatic moderate-to-severe or greater isolated aortic regurgitation meeting at least one of the following criteria: LVEF ≤ 55% (measured by biplane Simpson's method); LVESD \> 50 mm ; LVESDi \> 22 mm/mm²； LVESVi \> 45mL/m2 Anatomical suitability for TAVR as assessed by the heart team. Provision of written informed consent by the patient or their legal guardian, with agreement to the treatment plan and willingness and ability to comply with all required follow-up assessments. Exclusion Criteria Incomplete coronary revascularization. Less than 30 days of guideline-directed medical therapy at maximally tolerated doses. Life expectancy \< 1 year. LVEF \< 45%. eGFR \< 30 mL/min/1.73m². Known allergy or contraindication to required medications (e.g., aspirin, clopidogrel, warfarin) or contrast media. Any condition that precludes contrast-enhanced CT. Concurrent moderate-to-severe or severe valvular heart disease other than aortic regurgitation. Poor patient compliance, unable to complete follow-up as required. Any other condition that, in the investigator's judgment, would make the patient unsuitable for the study.

Primary outcome measure(s)

Clinical worsening — 12 months
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.

Trial sites (4)

Facility	City	Region	Status
Ruijin hospital, Shanghai JiaoTong University School of Medicine	Shanghai	Shanghai Municipality	Recruiting
Shanghai Chest Hospital	Shanghai	Shanghai Municipality	Recruiting
Zhongshan Hospital, Fudan University	Shanghai	Shanghai Municipality	Recruiting
Changhai Hospital	Shanghai	Shanghai Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06818084 on ClinicalTrials.gov ↗ ← All trials in China