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VitaFlow LIBERTY Europe

Recruitingn/aAges 18 Years - anyAllShanghai MicroPort CardioFlow Medtech Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

This is a prospective, single-arm, multi-center, observational, post-market clinical investigation 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 will receive transcatheter aortic valve replacement and examinations at the screening, procedure, discharge, and follow-up per local standard of care.

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

📋 Eligibility rules (as published)
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 consent form and is agreeing to the scheduled follow up requirements. Exclusion Criteria: 1. Pre-existing mechanical heart valve in aortic position 2. A known hypersensitivity or contraindication to all anticoagulation /antiplatelet regimens (or inability to be anticoagulated for the index procedure), to nickel or titanium, to nitinol, to dairy products, to polyethylene terephthalate (PET) or contrast media 3. Ongoing sepsis, including active endocarditis 4. Anatomically not suitable for the VitaFlow Liberty TAV system 5. LVEF\<20% 6. Estimated life expectancy of less than 12 months 7. Any medical, social or psychological condition that in the opinion of the Heart Team precludes the subject from receiving transcatheter aortic valve replacement 8. Currently participating in another drug or device trial (excluding registries) for which the primary endpoint has not been assessed 9. Inability to comply with the clinical investigation follow-up or other clinical investigation requirements 10. Patients temporally unable to provide written informed consent (e. g. unconscious emergency patients)
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What it tests

  • VitaFlow Liberty™ Transcatheter Aortic Valve System
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Where

9 sites
Galway University Hospital
Galway, Ireland
Pineta Grande Hospital
Castel Volturno, Italy
Ospedale Cisanello
Pisa, Italy
Azienda Ospedaliera Regionale -S.Carlo
Potenza, Italy
Hospital de Santa Cruz
Carnaxide, Portugal
Hospital Universitario de a Coruna
A Coruña, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital clinico Universitario de Valladolid
Valladolid, Spain

…and 1 more on ClinicalTrials.gov.

🤝 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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