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New heart valve fix without open surgery shows promise in Head-to-Head trial

NCT ID NCT04402931

Completed Disease control Sponsor: Instituto Dante Pazzanese de Cardiologia Source: ClinicalTrials.gov ↗

First seen Oct 01, 2025 · Last updated May 15, 2026 · Updated 26 times

Summary

This study compared two ways to treat a failed mitral heart valve: a newer, less invasive procedure called valve-in-valve (done through a tube in a vein) versus repeat open-heart surgery. 150 adults with symptoms like shortness of breath were randomly assigned to one of the two treatments. The goal was to see which approach is safer and works better in the medium to long term, looking at complications, survival, and how well the new valve works.

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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, 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

Conditions

Explore the condition pages connected to this study.

MITRAL PROSTHETIC VALVE STENOSIS AND REGURGITATION