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New heart valve implant offers hope for congenital heart patients

NCT ID NCT03110861

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026

Summary

This study tested a new valve called the Pulsta® Transcatheter Pulmonary Valve in 15 people with congenital heart disease and a faulty pulmonary valve. The valve is implanted through a catheter, avoiding open-heart surgery. Researchers checked if the valve improved blood flow and was safe to use over 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 implanted through a catheter)
What this could lead to
If successful, this valve could offer a less invasive option for people with congenital heart disease who need a new pulmonary valve, potentially avoiding open-heart surgery.
What could go wrong
This was a small early study with only 15 people, so results may not apply to everyone. As with any implant, there are risks of complications like valve leakage or device-related serious events.

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

15 people

The number who actually took part.

Started

Mar 2017

Finished

Jul 2024

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 pulmonary regurgitation (PR) (≥3+) or RVOT conduit obstruction with mean gradient \>35mmHg by echocardiography * pulmonary artery annulus or in situ conduit size of ≥16 and ≤26mm * Patient willing to provide written informed consent and comply with follow-up requirements Exclusion Criteria: * Pre-existing mechanical heart valve in any position * Obstruction of the central veins (pulmonic bioprosthesis delivery system to the heart) * Coronary artery compression * A known hypersensitivity to Aspirin or Heparin * Immunosuppressive disease * Active infectious disease (e.g. endocarditis, meningitis) * Estimated survival less than 6 months * Female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant.

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Conditions

The condition(s) this trial relates to.

congenital heart disease pulmonary valve insufficiency pulmonary valve stenosis

As listed by the trial registrant

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

Congenital heart defect Pulmonary valve stenosis Pulmonary valve; insufficiency, congenital

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, Olympic-ro, Songpa-gu, 05505, South Korea

  • Samsung Medical Center

    Seoul, Ilwon-ro, Gangnam-gu, 06351, South Korea

  • Sejong General Hospital

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

  • Seoul National University Hospital

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

  • Severance Hospital

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

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