New heart valve implant offers hope for congenital heart patients

NCT ID NCT03110861

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

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