Status:
RECRUITING
VitaFlow LIBERTY Europe
Lead Sponsor:
Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Brief Summary
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 Valv...
Eligibility Criteria
Inclusion
- Subjects of age≥ 18 years
- Subjects with severe, symptomatic, calcific aortic stenosis who are considered at high risk for surgical aortic valve replacement (AVR).
- 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
- Pre-existing mechanical heart valve in aortic position
- 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
- Ongoing sepsis, including active endocarditis
- Anatomically not suitable for the VitaFlow Liberty TAV system
- LVEF\<20%
- Estimated life expectancy of less than 12 months
- Any medical, social or psychological condition that in the opinion of the Heart Team precludes the subject from receiving transcatheter aortic valve replacement
- Currently participating in another drug or device trial (excluding registries) for which the primary endpoint has not been assessed
- Inability to comply with the clinical investigation follow-up or other clinical investigation requirements
- Patients temporally unable to provide written informed consent (e. g. unconscious emergency patients)
Key Trial Info
Start Date :
May 6 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2032
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT06535659
Start Date
May 6 2025
End Date
June 1 2032
Last Update
December 29 2025
Active Locations (6)
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1
Galway University Hospital
Galway, Ireland
2
Ospedale Cisanello
Pisa, Italy
3
Hospital Universitario de a Coruna
A Coruña, Spain
4
Hospital Clínico San Carlos
Madrid, Spain