New heart valve could spare patients from Open-Heart surgery

NCT ID NCT03983512

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

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for HEART DISEASES are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.