VitaFlow LIBERTY Europe
This trial has no sites in United States.
It has sites in 5 countries. Choose a country to see its sites.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
- Trial code
- NCT06535659
- Record updated
- 1 October 2026
- Original description
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.Read full original descriptionShow less
VitaFlow Liberty™ Transcatheter Aortic Valve System Post-market Clinical Follow-up Study
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.
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: 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; 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; LVEF<20%; Ongoing sepsis, including active endocarditis; Anatomically not suitable for the VitaFlow Liberty TAV system; Estimated life expectancy of less than 12 months; 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).