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RECRUITING
NCT06535659

VitaFlow LIBERTY Europe

Sponsor: Shanghai MicroPort CardioFlow Medtech Co., Ltd.

View on ClinicalTrials.gov

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.

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

222

Start Date

2025-05-06

Completion Date

2033-06

Last Updated

2026-10-01

Healthy Volunteers

No

Interventions

DEVICE

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 (9)

Galway University Hospital

Galway, Ireland

Pineta Grande Hospital

Castel Volturno, Italy

Ospedale Cisanello

Pisa, Italy

Azienda Ospedaliera Regionale -S.Carlo

Potenza, Italy

Hospital de Santa Cruz

Carnaxide, Portugal

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