NCT06535659

VitaFlow LIBERTY Europe

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 122 (estimated)
• Sponsor: Shanghai MicroPort CardioFlow Medtech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-05-06
• Primary completion: 2027-06-06
• Completion: 2032-06-01
• First posted: 2024-08-02
• Last updated: 2025-12-29

Locations

6 sites across 4 countries: Ireland, Italy, Spain, Switzerland