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New heart valve study aims to improve life for High-Risk patients

NCT ID NCT06535659

Disease control Sponsor: Shanghai MicroPort CardioFlow Medtech Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new heart valve replacement system (VitaFlow Liberty) in 122 people with severe aortic stenosis who are too high-risk for open-heart surgery. The goal is to see how safe and effective the valve is over 12 months, focusing on preventing death and disabling strokes. Participants will get the valve through a less invasive procedure and be followed up regularly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 122 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Jun 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic valve stenosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    6 sites in 4 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Galway University Hospital

    NOT_YET_RECRUITING

    Galway, Ireland

  • Hospital Clínico San Carlos

    RECRUITING

    Madrid, Spain

  • Hospital Universitario de a Coruna

    RECRUITING

    A Coruña, Spain

    Contact Email: •••••@•••••

  • Hospital clinico Universitario de Valladolid

    RECRUITING

    Valladolid, Spain

  • Luzerner Kantonsspital | Herzzentrum

    RECRUITING

    Lucerne, Switzerland

  • Ospedale Cisanello

    RECRUITING

    Pisa, Italy

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