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TRanscAtheter TreatMent of PurE Aortic Regurgitation With VitaFlow Liberty System

RecruitingPhase 4Ages 60 Years - anyAllRuijin Hospital
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In plain words

What the trial is, and whether it could suit you

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 im

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • VitaFlow+GDMT
  • J-Valve+GDMT
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Where

4 sites
Ruijin hospital, Shanghai JiaoTong University School of Medicine
Shanghai, China
Shanghai Chest Hospital
Shanghai, China
Zhongshan Hospital, Fudan University
Shanghai, China
Changhai Hospital
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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