VitaFlow LIBERTY Europe
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- Composite rate of all-cause mortality and stroke with disability — 12 months post procedure
Composite rate of all-cause mortality and stroke with disability
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| Galway University Hospital | Galway | Ireland | Recruiting |
| Pineta Grande Hospital | Castel Volturno | Italy | Recruiting |
| Ospedale Cisanello | Pisa | Italy | Recruiting |
| Azienda Ospedaliera Regionale -S.Carlo | Potenza | Italy | Recruiting |
| Hospital de Santa Cruz | Carnaxide | Portugal | Recruiting |
| Hospital Universitario de a Coruna | A Coruña | Spain | Recruiting |
| Hospital Clínico San Carlos | Madrid | Spain | Recruiting |
| Hospital clinico Universitario de Valladolid | Valladolid | Spain | Recruiting |
| Luzerner Kantonsspital | Herzzentrum | Lucerne | Switzerland | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06535659 on ClinicalTrials.gov ↗ ← All trials in Ireland