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Taking people in ItalyNo phase

VitaFlow LIBERTY Europe

Key facts

Who runs it
Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Where
Castel Volturno, Pisa, and Potenza, ItalySee the 3 sitesAlso in 4 other countries, 6 sites
Trial code
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

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

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 Italy

Also in 4 other countries, 6 sites

  • Pineta Grande HospitalCastel Volturno, ItalyContact: Alberto MorelloTaking people
  • Ospedale CisanelloPisa, ItalyContact: Dr.Marco De CarloTaking people
  • Azienda Ospedaliera Regionale S.CarloPotenza, ItalyContact: Eugenio StabileTaking 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
Record updated
1 October 2026