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.

Disclaimer Read more

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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Conditions

The condition(s) this trial relates to.

gastroesophageal reflux disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Hospital Ana Nery

    Salvador, Estado de Bahia, 41745900, Brazil

  • Hospital de Messejana Dr. Carlos Alberto Studart Gomes

    Fortaleza, Ceará, 60840285, Brazil

  • Instituto Dante Pazzanese de Cardiologia

    São Paulo, 04012909, Brazil

  • Instituto Nacional de Cardiologia

    Rio de Janeiro, Rio de Janeiro, 22240006, Brazil

  • Instituto de Cardiologia de Santa Catarina

    São José, Santa Catarina, 88103901, Brazil

  • Instituto do Coração (INCOR)

    São Paulo, São Paulo, 05403900, Brazil

  • UNIFESP

    São Paulo, São Paulo, 04021001, Brazil