New study pits tiny valve fix against major surgery for heart valve failure
NCT ID NCT04402931
First seen Jun 26, 2026 · Last updated Jul 01, 2026 · Updated 2 times
Summary
This study compared two ways to fix a failed mitral heart valve replacement: a less invasive procedure called valve-in-valve (using a catheter to place a new valve inside the old one) versus repeat open-heart surgery. The trial included 150 adults with severe valve problems. Researchers tracked major events like death, stroke, and complications to see which approach is safer and works better over time.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- Transcatheter mitral valve-in-valve implantation with SAPIEN 3
- What this could lead to
- If successful, this could show that a less invasive procedure is as good as or better than repeat open-heart surgery for people with a failed mitral valve replacement.
- What could go wrong
- This is a completed trial with 150 participants, so results are limited. Long-term durability of the valve-in-valve approach is still unknown, and there are risks like stroke, bleeding, or heart rhythm problems.
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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hospital Ana Nery
Salvador, Estado de Bahia, 41745900, Brazil
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Hospital de Messejana Dr. Carlos Alberto Studart Gomes
Fortaleza, Ceará, 60840285, Brazil
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Instituto Dante Pazzanese de Cardiologia
São Paulo, 04012909, Brazil
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Instituto Nacional de Cardiologia
Rio de Janeiro, Rio de Janeiro, 22240006, Brazil
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Instituto de Cardiologia de Santa Catarina
São José, Santa Catarina, 88103901, Brazil
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Instituto do Coração (INCOR)
São Paulo, São Paulo, 05403900, Brazil
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UNIFESP
São Paulo, São Paulo, 04021001, Brazil