New heart valve could spare patients from Open-Heart surgery
NCT ID NCT03983512
First seen Dec 18, 2025 · Last updated Jun 22, 2026 · Updated 30 times
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.
Disclaimer
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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.
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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Contacts and locations
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Locations
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Deutsches Herzzentrum Munchen
München, München, 80636, Germany
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Erasmus Medical Center
Rotterdam, Wytemaweg, 3015, Netherlands
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Gregorio Marañon hospital
Madrid, Madrid, 28007, Spain
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Koc University Hospital
Istanbul, Topkapı, Zetinburnu/İstanbul, 34010, Turkey (Türkiye)
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Policlinico San Donato
Milan, San Donato Milanese, 20097, Italy
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Sejong General Hospital
Bucheon-si, Hohyun-ro, Sosa-gu, 14754, South Korea
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Seoul National University Hospital
Seoul, Daehak-ro Jongno-gu, 03080, South Korea
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Severance Hospital
Seoul, Yonsei-ro, Seodaemun-gu, 03722, South Korea
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Siyami Ersek Hospital
Istanbul, Üsküdar/İstanbul, 34668, Turkey (Türkiye)
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University Hospital La Paz
Madrid, Madrid, 28046, Spain
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Utrecht University Wilhelmina
Utrecht, Utrecht, 3508, Netherlands
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.
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.