New heart valve implant offers hope for congenital heart patients

NCT ID NCT03110861

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

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.

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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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