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

NCT ID NCT07747207

Not yet recruiting Disease control Sponsor: Taewoong Medical Co., Ltd. Source: ClinicalTrials.gov ↗

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.

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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

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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