VitaFlow System for Aortic Regurgitation Treatment
TRanscAtheter TreatMent of PurE Aortic Regurgitation With VitaFlow Liberty System
Recruiting
Phase 4
Interventional Study
AORTIC VALVE DISEASES
Aortic Regurgitation
Transcatheter Aortic Valve Replacement (TAVR)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 60 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 120 (estimated)
- Sponsor
- Ruijin Hospital · Other
Who this trial is looking for
This trial is looking for patients with pure aortic regurgitation to test a new treatment. Participants will receive a specific heart valve replacement procedure and undergo follow-up assessments.
Are You a Good Fit for This Trial?
You may be able to join if
- I am at least 60 years old.
- I have moderate-to-severe aortic regurgitation.
- I have a left ventricular ejection fraction of 55% or less.
- I have the anatomy suitable for this type of heart valve replacement.
- I can give written consent for the treatment plan.
- I am willing to follow all required assessments.
You may not be able to join if
- I have not had coronary revascularization completed.
- I have been on less than 30 days of medical therapy for my condition.
- I have a life expectancy of less than 1 year.
- I have a left ventricular ejection fraction of less than 45%.
- My kidney function is very low.
- I have an allergy to medications that are needed for this trial.
- I have other serious heart valve diseases.
- I cannot complete follow-ups as required.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
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Answer a few quick questions to see if you may meet the eligibility requirements.
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About This Trial
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 transfe…
Trial Locations
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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 ; L…
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