RecruitingNCT06535659

VitaFlow LIBERTY Europe

VitaFlow Liberty™ Transcatheter Aortic Valve System Post-market Clinical Follow-up Study

Sponsor

Shanghai MicroPort CardioFlow Medtech Co., Ltd.

Enrollment

122 participants

Start Date

May 6, 2025

Study Type

OBSERVATIONAL

Conditions

Aortic Valve Stenosis

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called VitaFlow Liberty™ Transcatheter Aortic Valve System for people with aortic valve stenosis. The study is currently recruiting participants at 6 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVitaFlow 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.