Actively Recruiting
VitaFlow LIBERTY Europe
Led by Shanghai MicroPort CardioFlow Medtech Co., Ltd. · Updated on 2025-12-29
122
Participants Needed
6
Research Sites
369 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 will receive transcatheter aortic valve replacement and examinations at the screening, procedure, discharge, and follow-up per local standard of care.
CONDITIONS
Official Title
VitaFlow LIBERTY Europe
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Galway University Hospital
Galway, Ireland
Not Yet Recruiting
2
Ospedale Cisanello
Pisa, Italy
Actively Recruiting
3
Hospital Universitario de a Coruna
A Coruña, Spain
Actively Recruiting
4
Hospital Clínico San Carlos
Madrid, Spain
Actively Recruiting
5
Hospital clinico Universitario de Valladolid
Valladolid, Spain
Actively Recruiting
6
Luzerner Kantonsspital | Herzzentrum
Lucerne, Switzerland
Actively Recruiting
Research Team
L
Luying Yan
CONTACT
Z
Zhujun Cai, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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