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Recruiting NCT06535659

VitaFlow LIBERTY Europe

— Observational Aortic Valve Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VitaFlow Liberty™ Transcatheter Aortic Valve System.
Who it may be relevant to
Registry conditions: Aortic Valve Stenosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Ireland, Italy, Spain, Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

VitaFlow Liberty™ Transcatheter Aortic Valve System Post-market Clinical Follow-up Study

Overview

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.

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.

Primary outcome measures

  • Composite rate of all-cause mortality and stroke with disability [Time frame: 12 months post procedure]
Secondary outcome measures (12)
  • Safety outcomes defined by VARC3 [Time frame: 30 days, 12 months, and 2-5 years post procedure]
  • Safety outcomes defined by VARC3 [Time frame: 30 days and 12 months post procedure]
  • Safety outcomes defined by VARC3 [Time frame: acute procedure (within 24 hours)]
  • Device success [Time frame: 30 days post implantation]
  • Device early safety [Time frame: 30 days post implantation]
  • Bioprosthesis haemodynamic function [Time frame: Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation]
  • Bioprosthesis haemodynamic function [Time frame: Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation]
  • Bioprosthesis haemodynamic function [Time frame: Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation]
  • Bioprosthetic valve dysfunction [Time frame: 12 months and 2-5 years post procedure]
  • Bioprosthetic valve dysfunction [Time frame: 12 months and 2-5 years post procedure]
  • Bioprosthetic valve dysfunction [Time frame: 12 months and 2-5 years post procedure]
  • NYHA Classification [Time frame: From baseline to discharge (24 hours to 7 days), 30 days, 12 months and 2-5 years post procedure]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • Ongoing sepsis, including active endocarditis
  • Anatomically not suitable for the VitaFlow Liberty TAV system
  • LVEF<20%
  • Estimated life expectancy of less than 12 months
  • 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
  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 3 centers
  • Hospital Universitario de a Coruna — A Coruña
  • Hospital Clínico San Carlos — Madrid
  • Hospital clinico Universitario de Valladolid — Valladolid
Ireland · 1 center
  • Galway University Hospital — Galway
Italy · 1 center
  • Ospedale Cisanello — Pisa
Switzerland · 1 center
  • Luzerner Kantonsspital | Herzzentrum — Lucerne

Identifiers

NCT: NCT06535659 · VitaFlow EU-2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗