MedTrace Logo

VitaFlow LIBERTY Europe

NCT06535659 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 122

Last updated 2025-12-29

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Shanghai MicroPort CardioFlow Medtech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Darren Mylotte, MD · Galway University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-06
Primary Completion
2027-06-06
Completion
2032-06-30

Countries

  • Ireland
  • Italy
  • Spain
  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06535659 on ClinicalTrials.gov