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Taking people in PortugalNo phase

Follow-up of the VitaFlow Liberty heart valve in severe aortic valve stenosis

Follows adults with severe aortic valve stenosis who receive the VitaFlow Liberty replacement valve.

Key facts

Who runs it
Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Where
Carnaxide, PortugalSee the siteAlso in 4 other countries, 8 sites
Trial code
Registry title
VitaFlow LIBERTY Europe
Status
Recruiting
People taking part
222 people, planned
Started
6 May 2025
Expected to end
Jun 2033
Type of study
Observational
Treatments tested
  • VitaFlow Liberty™ Transcatheter Aortic Valve System
Record updated
1 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with severe aortic valve narrowing that causes symptoms. They will get a new heart valve placed through a catheter (VitaFlow Liberty™), as in routine care.

Age
18 years and older
Sex
All sexes
Disease stage
Severe, symptomatic, calcific aortic stenosis (narrowed aortic valve with calcium build-up). People must be at high risk for open-heart valve surgery (AVR).
Earlier treatment
People who already have a mechanical heart valve in the aortic position cannot join.

Main reasons for not taking part

  • Known allergy or reaction to all blood-thinning drugs, to nickel, titanium, nitinol, dairy products, PET or contrast dye
  • Ongoing serious infection (sepsis), including active infection of the heart valves (endocarditis)
  • Heart anatomy that does not fit the VitaFlow Liberty TAV system
  • Heart pumping strength (LVEF) below 20%
  • Expected to live less than 12 months

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • Subjects of age≥ 18 years
  • Subjects with severe, symptomatic, calcific aortic stenosis who are considered at high risk for surgical aortic valve replacement (AVR)
  • Subject can understand the purpose of the clinical investigation, has signed voluntarily the informed consent form and is agreeing to the scheduled follow up requirements

Who cannot take part

  • Any medical, social or psychological condition that in the opinion of the Heart Team precludes the subject from receiving transcatheter aortic valve replacement
  • Currently participating in another drug or device trial (excluding registries) for which the primary endpoint has not been assessed
  • Pre-existing mechanical heart valve in aortic position
  • A known hypersensitivity or contraindication to all anticoagulation /antiplatelet regimens (or inability to be anticoagulated for the index procedure), to nickel or titanium, to nitinol, to dairy products, to polyethylene terephthalate (PET) or contrast media
  • LVEF<20%
  • Ongoing sepsis, including active endocarditis
  • Anatomically not suitable for the VitaFlow Liberty TAV system
  • Estimated life expectancy of less than 12 months
  • Inability to comply with the clinical investigation follow-up or other clinical investigation requirements
  • Patients temporally unable to provide written informed consent (e. g. unconscious emergency patients)

Where in Portugal

Also in 4 other countries, 8 sites

  • Hospital de Santa CruzCarnaxide, PortugalTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

Patients will receive transcatheter aortic valve replacement and examinations at the screening, procedure, discharge, and follow-up per local standard of care.

The group in the trial

  • Single arm clinical investigation

    Treatment: VitaFlow Liberty™ Transcatheter Aortic Valve System

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
VitaFlow Liberty™ Transcatheter Aortic Valve System Post-market Clinical Follow-up Study
Plain-language title
Follow-up of the VitaFlow Liberty heart valve in severe aortic valve stenosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
1 October 2026