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NCT Number: NCT06535659

VitaFlow LIBERTY Europe

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.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Galway University Hospital, Galway, Ireland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

VitaFlow Liberty™ Transcatheter Aortic Valve System

Device

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 outcomes

  1. Composite rate of all-cause mortality and stroke with disability

    Time frame: 12 months post procedure

    Composite rate of all-cause mortality and stroke with disability

Secondary outcomes

  1. Safety outcomes defined by VARC3

    Time frame: 30 days, 12 months, and 2-5 years post procedure

    Rate of all-cause mortality, myocardial infarction, stroke, implanted related new and/or worsen conduction disturbances and arrhythmias, new permanent pacemaker implantation, procedure-related or valve-related hospitalization defined by VARC 3.

  2. Safety outcomes defined by VARC3

    Time frame: 30 days and 12 months post procedure

    Rate of type 2-4 bleeding, major vascular and access-related complications, acute kidney injury (stage 2-4) defined by VARC 3

  3. Safety outcomes defined by VARC3

    Time frame: acute procedure (within 24 hours)

    Rate of other acute procedural and technical valve related complications: conversion to surgery; unplanned use of mechanical circulatory support; implantation of multiple (>1) transcatheter valves during the index hospitalization; valve mal-position

  4. Device success

    Time frame: 30 days post implantation

    Device success defined by VARC 3

  5. Device early safety

    Time frame: 30 days post implantation

    Device early safety defined by VARC 3

  6. Bioprosthesis haemodynamic function

    Time frame: Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation

    Bioprosthesis haemodynamic function (assessed by echocardiography) including effective orifice area (cm2).

  7. Bioprosthesis haemodynamic function

    Time frame: Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation

    Bioprosthesis haemodynamic function (assessed by echocardiography) including mean transvalvular gradient (mmHg).

  8. Bioprosthesis haemodynamic function

    Time frame: Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation

    Bioprosthesis haemodynamic function (assessed by echocardiography) including aortic regurgitation (paravalvular, central and total).

  9. Bioprosthetic valve dysfunction

    Time frame: 12 months and 2-5 years post procedure

    Moderate or severe haemodynamic valve deterioration defined by VARC3

  10. Bioprosthetic valve dysfunction

    Time frame: 12 months and 2-5 years post procedure

    Bioprosthetic valve failure defined by VARC3

  11. Bioprosthetic valve dysfunction

    Time frame: 12 months and 2-5 years post procedure

    Clinically significant valve thrombosis defined by VARC3

  12. NYHA Classification

    Time frame: From baseline to discharge (24 hours to 7 days), 30 days, 12 months and 2-5 years post procedure

    Changes in cardiac function at discharge, 30 days and 12 months and 2-5 years post implantation according to the NYHA Classification Scheme compared to baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Luying Yan

CONTACT

[email protected]

86-010-66513642

Zhujun Cai, PhD

CONTACT

[email protected]

86-021-38954600

Sponsors and collaborators

Lead sponsor

Shanghai MicroPort CardioFlow Medtech Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2032
First posted
Aug 2, 2024
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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