RecruitingAge-related condition
VitaFlow LIBERTY Europe
VitaFlow Liberty™ Transcatheter Aortic Valve System Post-market Clinical Follow-up Study
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd. (Industry)
- Enrolment
- 222 planned
- Conditions
- Aortic Valve Stenosis
- Interventions
- VitaFlow Liberty™ Transcatheter Aortic Valve System
- Ages
- adults, older adults
- Registry
- NCT06535659
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Composite rate of all-cause mortality and stroke with disability
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered