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New heart valve could spare patients from Open-Heart surgery

NCT ID NCT03983512

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a new device called the PULSTA valve, which is placed inside the heart through a tube in a blood vessel, avoiding open-heart surgery. It is for 58 people with a leaky or narrowed pulmonary valve, often due to a birth defect. The goal is to see if the valve is safe and works well at 6 months.

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 (a replacement heart valve delivered through a tube in a blood vessel)
What this could lead to
If successful, this could provide a less invasive option for replacing a faulty pulmonary valve, avoiding open-heart surgery.
What could go wrong
This is a small, early-stage study with only 58 people. The valve may not work for everyone, and there are risks like serious side effects or the valve needing to be removed.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 58 people

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

Started

Oct 2019

Expected to finish

Dec 2026

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.

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: * Body weight greater than or equal to 30 kilograms * Pulmonary regurgitation moderate or severe pulmonary regurgitation or pulmonary valve stenosis with mean gradient \>35mmHg by echocardiography * Main pulmonary artery trunk of ≥16 mm and ≤30 mm * Patients willing to provide written informed consent and comply with follow-up evaluations. Exclusion Criteria: * Females of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant up until 6 months after TPV implantation * Pre-existing mechanical valve in pulmonary position or require concomitant repair of other cardiac valves * Obstruction of the central veins to be approached for the TPV implantation * Coronary artery compression confirmed by angiography * A known severe allergy to Nickel * A known hypersensitivity to any anticoagulation therapy, contrast agent or a hemorrhagic disease * Suspected active infectious disease (e.g. endocarditis, meningitis) * Life expectancy of less than 6 months

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Conditions

The condition(s) this trial relates to.

heart disorder pulmonary valve insufficiency pulmonary valve stenosis tetralogy of fallot

As listed by the trial registrant

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

Heart diseases Pulmonary valve regurgitation Pulmonary valve stenosis Tetralogy of fallot

Contacts and locations

Locations

  • Deutsches Herzzentrum Munchen

    München, München, 80636, Germany

  • Erasmus Medical Center

    Rotterdam, Wytemaweg, 3015, Netherlands

  • Gregorio Marañon hospital

    Madrid, Madrid, 28007, Spain

  • Koc University Hospital

    Istanbul, Topkapı, Zetinburnu/İstanbul, 34010, Turkey (Türkiye)

  • Policlinico San Donato

    Milan, San Donato Milanese, 20097, Italy

  • Sejong General Hospital

    Bucheon-si, Hohyun-ro, Sosa-gu, 14754, South Korea

  • Seoul National University Hospital

    Seoul, Daehak-ro Jongno-gu, 03080, South Korea

  • Severance Hospital

    Seoul, Yonsei-ro, Seodaemun-gu, 03722, South Korea

  • Siyami Ersek Hospital

    Istanbul, Üsküdar/İstanbul, 34668, Turkey (Türkiye)

  • University Hospital La Paz

    Madrid, Madrid, 28046, Spain

  • Utrecht University Wilhelmina

    Utrecht, Utrecht, 3508, Netherlands

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