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New heart valve registry aims to improve aortic stenosis treatment

NCT ID NCT06818435

Disease control Sponsor: Portuguese Association of Interventional Cardiology 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This registry will follow 150 people in Portugal who receive the Myval heart valve through a minimally invasive procedure called TAVI. The goal is to see how safe and effective the valve is for treating severe aortic stenosis. Researchers will track complications like death, stroke, kidney injury, and bleeding over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Myval THV series (a replacement heart valve implanted via a catheter)
What this could lead to
If successful, this registry could confirm that the Myval valve is a safe and effective option for treating severe aortic stenosis without open-heart surgery.
What could go wrong
This is an observational registry, not a controlled trial, so results may be less definitive. Risks include serious complications like stroke, bleeding, or need for a pacemaker.

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 150 people

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

Started

May 2025

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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 native aortic valve stenosis who underwent TAVI using Myval THV series as assessed by Heart Team and Investigator.

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. Patient over the age of 18 years with symptomatic aortic stenosis (severe AS), intended to perform TAVI procedure using Myval THV series as assessed by Heart Team. 2. Patient has provided written informed consent as approved by the Ethics Committee (EC) 3. Patient is willing to undergo all registry procedures and follow-up requirements Exclusion Criteria: 1. Patients with hyper sensitivity or allergy to aspirin, heparin, clopidogrel, ticlopidine, cobalt, nickel, chromium, molybdenum or any contrast media. 2. Ongoing infective endocarditis or any similar infection. 3. Pregnant or lactating females. 4. Liver failure (Child-Pugh Class B or C) 5. Patient is currently participating in another clinical investigation where the primary endpoint has not been achieved. 6. Any condition, which in the investigator opinion, would preclude safe participation of the patient in the Registry.

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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 Tavi(transcatheter aortic valve implantation)

How to take part

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

  1. The places running it

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

  2. 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 ↗

  3. 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

  • Unidade Local de Saúde Alentejo Central E.P.E. - Hospital Espírito Santo

    RECRUITING

    Evora, 7000-811, Portugal

  • Unidade Local de Saúde de Coimbra

    RECRUITING

    Coimbra, 3004-561, Portugal

  • Unidade Local de Saúde de Santa Maria, E.P.E. - Hospital de Santa Maria

    RECRUITING

    Lisbon, 1649-035, Portugal

  • Unidade Local de Saúde de São José E.P.E. - Hospital Santa Marta

    NOT_YET_RECRUITING

    Lisbon, 1169-024, Portugal

  • Unidade Local de Saúde do Lisboa Ocidental E.P.E. - Hospital Santa Cruz

    RECRUITING

    Carnaxide, 2790-134, Portugal

  • Unidade Local de São João E.P.E.

    NOT_YET_RECRUITING

    Porto, 4200-319, Portugal

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