Transfemoral VitaFlow Liberty treatment for pure aortic regurgitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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.
• Email: zzb11561@rjh.com.cn
• Phone: 0086-15601950612

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.