VitaFlow Liberty for Severe Aortic Valve Stenosis
VitaFlow LIBERTY Europe
Recruiting
Observational Study
Aortic Valve Stenosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 122 (estimated)
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd. · Industry
Who this trial is looking for
This trial is looking for adults with severe aortic valve stenosis who are at high risk for surgery. Participants will receive a special heart valve and have follow-up exams to check how they are doing.
Are You a Good Fit for This Trial?
You may be able to join if
- I am at least 18 years old.
- I have severe, symptomatic aortic stenosis.
- I am considered at high risk for heart surgery.
- I understand the study and have signed the consent form.
You may not be able to join if
- I have a mechanical heart valve in the aortic position.
- I cannot take anticoagulation or antiplatelet medications.
- I have ongoing sepsis or active endocarditis.
- I am not anatomically suitable for the procedure.
- My heart function (LVEF) is less than 20%.
- My life expectancy is less than 12 months.
- I have a condition that would prevent me from having the procedure.
- I am currently in another clinical trial that is not a registry.
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 is a prospective, single-arm, multi-center, observational, post-market registry to document the clinical safety and performance of MicroPort CardioFlow VitaFlow Liberty™ Transcatheter Aortic Valve System in the routine practice for the treatment of severe aortic valve stenosis. The primary endpoint is the composite rate of all-cause mortality and stroke with disability at 12 months.
Patients…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Subjects of age≥ 18 years
2. Subjects with severe, symptomatic, calcific aortic stenosis who are considered at high risk for surgical aortic valve replacement (AVR).
3. Subject can understand the purpose of the clinical investigation, has signed voluntarily the informed conse…
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