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Can a new heart valve offer lasting relief for pulmonary stenosis?

NCT ID NCT07747207

Disease control Sponsor: Taewoong Medical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 05, 2026 · Last updated Aug 11, 2026 · Updated 3 times

Summary

This study follows people with moderate to severe pulmonary regurgitation or stenosis who receive the PULSTA transcatheter pulmonary valve, a less invasive option for replacing a faulty heart valve. Researchers will track how well the valve works over time, measuring improvements in blood flow and heart function, as well as any serious complications. The goal is to understand the valve's long-term safety and effectiveness in real-world use.

What this could mean

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

Active substance
PULSTA transcatheter pulmonary valve (TPV) implantation
What this could lead to
If successful, this study could confirm that the PULSTA valve provides lasting improvement in heart function and quality of life for people with pulmonary valve problems.
What could go wrong
Because this is an observational study, it cannot prove cause and effect. Long-term results may vary, and there are risks of procedural complications or device-related issues.

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 200 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2033

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 right ventricular outflow tract (RVOT) dysfunction who are considered eligible for percutaneous pulmonary valve implantation (PPVI) with the PULSTA TPV according to the approved indication and routine clinical practice at participating centers.

Ages

10 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: * Patients with moderate to severe pulmonary regurgitation and/or pulmonary stenosis who undergo transcatheter pulmonary valve implantation using the PULSTA Transcatheter Pulmonary Valve(TPV). * Patients who are willing to participate in the study and who have voluntarily provided written informed consent. Exclusion Criteria: * Patients who have not signed informed consent * Patients who are contraindicated for the implantation per the device's Instructions for Use.

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Conditions

The condition(s) this trial relates to.

heart disorder pulmonary valve insufficiency pulmonary valve stenosis pulmonic stenosis tetralogy of fallot

As listed by the trial registrant

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

Heart disease

How to take part

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

  1. The places running it

    9 sites in 6 countries. 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

  • Bucheon Sejong Hospital

    Bucheon-si, Gyeonggi-do, 14754, South Korea

  • Deutsches Herzzentrum München

    Munich, Bavaria, 80636, Germany

  • Koc University Hospital (Istanbul)

    Istanbul, Istanbul, 34010, Turkey (Türkiye)

  • La Paz Hospital (Madrid)

    Madrid, Madrid, 28046, Spain

  • Ospedale Niguarda (Milano)

    Milan, Lombardy, 20162, Italy

  • Polish Mother's memorial hospital

    Lodz, Łódź Voivodeship, 93-338, Poland

  • Seoul National University Hospital (Seoul)

    Seoul, 3080, South Korea

  • Severance Hospital (Seoul)

    Seoul, 3722, South Korea

  • Siyami Ersek Hospital (Istanbul)

    Istanbul, Istanbul, 34668, Turkey (Türkiye)

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