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Recruiting
NCT06535659
VitaFlow LIBERTY Europe
Conditions: Aortic Valve Stenosis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 222
Sponsor: Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Location: Galway University Hospital Galway
Summary
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.
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 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\
Source: ClinicalTrials.gov (NCT06535659). StuddyBuddy aggregates publicly available trial information.