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New heart valve fix without open surgery shows promise in High-Risk patients

NCT ID NCT03039855

Completed Disease control Sponsor: Shockwave Medical, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new device called the Tiara valve, which is implanted through a small tube in the chest to replace the leaky mitral valve without open-heart surgery. It enrolled 157 people with severe mitral regurgitation who were considered too high-risk for traditional surgery. The main goals were to see if the device could safely reduce the valve leakage and improve survival and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
Tiara mitral valve and delivery system (a device implanted via a tube through the chest to replace the leaky heart valve)
What this could lead to
If it works, this could offer a less invasive option for people with severe mitral regurgitation who are too high-risk for open-heart surgery.
What could go wrong
This is a completed early-stage study without a control group, so results may not apply to all patients. Device implantation carries risks like bleeding, infection, or valve failure.

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.

gastroesophageal reflux disease mitral valve insufficiency

As listed by the trial registrant

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

MITRAL VALVE REGURGITATION

Contacts and locations

Locations

  • Deutches Herzzentrum Berlin

    Berlin, 13353, Germany

  • Edinburgh Heart Centre Royal Infirmary

    Edinburgh, EH16 4SA, United Kingdom

  • Fondazione Policlinico Universitario A. Gemelli - Università Cattolica del Sacro Cuore.

    Roma, RM, 00168, Italy

  • Fondazione Toscana 'Gabriele Monasterio'

    Massa, 54100, Italy

  • Herz- und Diabeteszentrum NRW

    Bad Oeynhausen, 32545, Germany

  • Herz-Kreislauf-Zentrum Klinikum Hersfeld Rotenburg

    Rotenburg an der Fulda, Germany

  • Herzzentrum Leipzig

    Leipzig, 04289, Germany

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • IRCCS Policlinico San Donato

    San Donato Milanese, 20097, Italy

  • Immanuel Klinikum Bernau und Herzzentrum Brandenburg

    Bernau, 16321, Germany

  • Kerckhoff Klinik Herzzentrum-Herzchirurgie

    Bad Nauheim, 61231, Germany

  • King's College Hospital

    London, SE59RS, United Kingdom

  • Ospedale San Raffaele

    Milan, 20132, Italy

  • Sana Herzchirurgie Stuttgart GmbH

    Stuttgart, 70174, Germany

  • Schüchtermann-Klinik

    Bad Rothenfelde, 49214, Germany

  • St. Antonius Hospital

    Nieuwegein, Netherlands

  • St.-Johannes-Hospital, Klinik für Innere Medizin I

    Dortmund, 44229, Germany

  • Tel Aviv Medical Center

    Tel Aviv, Israel

  • Universitasklinikum Hamburg-Eppendorf

    Hamburg, 20246, Germany

  • Universitätsklinikum Halle

    Halle, 06120, Germany

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