VitaFlow LIBERTY Europe

September 28, 2026 updated by: Shanghai MicroPort CardioFlow Medtech Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
222

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Ireland
      • Galway, Ireland
        • Recruiting
        • Galway University Hospital
        • Contact:
          • Darren Mylotte, MD
  • Italy
      • Castel Volturno, Italy
      • Pisa, Italy
        • Recruiting
        • Ospedale Cisanello
        • Contact:
      • Potenza, Italy
        • Recruiting
        • Azienda Ospedaliera Regionale -S.Carlo
        • Contact:
  • Portugal
      • Carnaxide, Portugal
        • Recruiting
        • Hospital de Santa Cruz
        • Contact:
  • Spain
      • A Coruña, Spain
        • Recruiting
        • Hospital Universitario de a Coruna
        • Contact:
      • Madrid, Spain
      • Valladolid, Spain
  • Switzerland
      • Lucerne, Switzerland
        • Recruiting
        • Luzerner Kantonsspital | Herzzentrum
        • Contact:
          • Dr.Stefan Toggweiler
          • Phone Number: 0412051111
          • Email: ifo@luks.ch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with symptomatic, severe calcified aortic stenosis who are at high surgical risk.

Description

Inclusion Criteria:

  1. Subjects of age≥ 18 years
  2. Subjects with severe, symptomatic, calcific aortic stenosis who are considered at high risk for surgical aortic valve replacement (AVR).
  3. 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:

  1. Pre-existing mechanical heart valve in aortic position
  2. 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
  3. Ongoing sepsis, including active endocarditis
  4. Anatomically not suitable for the VitaFlow Liberty TAV system
  5. LVEF<20%
  6. Estimated life expectancy of less than 12 months
  7. Any medical, social or psychological condition that in the opinion of the Heart Team precludes the subject from receiving transcatheter aortic valve replacement
  8. Currently participating in another drug or device trial (excluding registries) for which the primary endpoint has not been assessed
  9. Inability to comply with the clinical investigation follow-up or other clinical investigation requirements
  10. Patients temporally unable to provide written informed consent (e. g. unconscious emergency patients)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Single arm clinical investigation
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
12 months post procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
30 days, 12 months, and 2-5 years post procedure
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
30 days and 12 months post procedure
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
acute procedure (within 24 hours)
Device success
Time Frame: 30 days post implantation

Device success defined by VARC 3
30 days post implantation
Device early safety
Time Frame: 30 days post implantation

Device early safety defined by VARC 3
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 (assessed by echocardiography) including effective orifice area (cm2).
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 (assessed by echocardiography) including mean transvalvular gradient (mmHg).
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 (assessed by echocardiography) including aortic regurgitation (paravalvular, central and total).
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

Moderate or severe haemodynamic valve deterioration defined by VARC3
12 months and 2-5 years post procedure
Bioprosthetic valve dysfunction
Time Frame: 12 months and 2-5 years post procedure

Bioprosthetic valve failure defined by VARC3
12 months and 2-5 years post procedure
Bioprosthetic valve dysfunction
Time Frame: 12 months and 2-5 years post procedure

Clinically significant valve thrombosis defined by VARC3
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

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
From baseline to discharge (24 hours to 7 days), 30 days, 12 months and 2-5 years post procedure
Rate of Alwide Plus Balloon Catheter pre-dilation success
Time Frame: During procedure

Defined as successful access, delivery and dilation the aortic valve, and retrieval for the AlwideTM Plus balloon catheter
During procedure
Alwide Plus Balloon Catheter related adverse-event
Time Frame: Discharge
Discharge
Predictors for the permanent pacemaker implantation
Time Frame: Baseline or intraprocedure

Including but not limited to pre-existing conduction disturbance, implant depth, LVOT calcium volume , post-dilatation
Baseline or intraprocedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai MicroPort CardioFlow Medtech Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Darren Mylotte, MD, Galway University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 6, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 6, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2033

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VitaFlow EU-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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