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VitaFlow LIBERTY Europe
Sponsor: Shanghai MicroPort CardioFlow Medtech Co., Ltd.
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 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.
Official title: VitaFlow Liberty™ Transcatheter Aortic Valve System Post-market Clinical Follow-up Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
122
Start Date
2025-05-06
Completion Date
2032-06
Last Updated
2025-12-29
Healthy Volunteers
No
Conditions
Interventions
VitaFlow Liberty™ Transcatheter Aortic Valve System
Transcatheter Aortic Valve Replacement with VitaFlow Liberty™ Transcatheter Aortic Valve System. Patients will receive transcatheter aortic valve replacement and examinations at the screening, procedure, discharge, and follow-up per local standard of care.
Locations (6)
Galway University Hospital
Galway, Ireland
Ospedale Cisanello
Pisa, Italy
Hospital Universitario de a Coruna
A Coruña, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital clinico Universitario de Valladolid
Valladolid, Spain
Luzerner Kantonsspital | Herzzentrum
Lucerne, Switzerland