Transfemoral VitaFlow Liberty treatment for pure aortic regurgitation

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

This trial will test whether replacing the aortic valve through the leg with the VitaFlow Liberty valve plus usual medical care helps people aged 60 and older with moderate-to-severe or worse isolated aortic regurgitation.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Ruijin Hospital (other)
• Locations: 4 sites (Shanghai, Shanghai Municipality and 3 other locations)
• Trial ID: NCT06818084 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, non-randomized controlled trial planning to enroll 180 patients with pure native aortic regurgitation who are suitable for transfemoral TAVR. Patients will be assigned 1:1 to receive transfemoral TAVR with the VitaFlow Liberty system plus guideline-directed medical therapy or a dedicated transcatheter device plus guideline-directed medical therapy. The primary endpoint is a composite of all-cause mortality, disabling stroke, and rehospitalization for heart failure, myocardial infarction, dialysis requirement, or valve reoperation at 12 months. Secondary outcomes include procedural complications, long-term clinical events, imaging measures of leaflet thickening and motion by CTA, serial echocardiographic measures, functional status and quality of life scores, and treatment costs.

Who should consider this trial

Good fit: Ideal candidates are adults aged 60 or older with symptomatic moderate-to-severe or greater isolated native aortic regurgitation (or selected asymptomatic patients meeting cardiac dimension or function criteria) who are anatomically suitable for transfemoral TAVR and can undergo contrast CT and follow-up visits.

Not a fit: Patients with very low life expectancy (<1 year), severely reduced LVEF (<45%), advanced renal failure (eGFR <30 mL/min/1.73 m²), incomplete coronary revascularization, contraindications to contrast or required antiplatelet/anticoagulant drugs, or inability to tolerate CT imaging are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this approach could reduce death, stroke, and heart-failure rehospitalizations and improve valve function and symptoms for patients who cannot or prefer not to undergo open surgery.

How similar studies have performed: Other transcatheter valves and dedicated devices (including J-Valve and other TAVR systems) have shown promising but mixed results in pure aortic regurgitation, with growing but still limited comparative evidence.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality and 3 other locations

• Ruijin hospital, Shanghai JiaoTong University School of Medicine — Shanghai, Shanghai Municipality, China (RECRUITING)
• Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)
• Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (RECRUITING)
• Changhai Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Principal investigator: ZhengBin Zhu, MD. PhD — Ruijin Hospital
• Study coordinator: Zhengbin Zhu, MD. PhD.

Conditions: AORTIC VALVE DISEASES, Aortic Regurgitation, Transcatheter Aortic Valve Replacement, pure aortic regurgitation, Transcatheter aortic valve replacement, hypoattenuated leaflet thickening, reduced leaflet motion