New heart valve device tested in 500 patients

NCT ID NCT05956652

First seen May 01, 2026

Summary

This study is testing a new device called the Hydra Transcatheter Aortic Valve System in 500 people with severe aortic stenosis, a condition where the heart's aortic valve becomes narrow. The device is implanted through a catheter, avoiding open-heart surgery. Researchers will track how well the valve works and monitor for complications like stroke or bleeding over time.

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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.

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Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Fondazione Poliambulanza Istituto

    RECRUITING

    Brescia, 25124, Italy

  • IRCCS Ospedale Galeazzi-Sant'Ambrogio

    NOT_YET_RECRUITING

    Milan, 20157, Italy

  • Montevergine Clinic, Mercogliano, Italy

    RECRUITING

    Mercogliano, 83013, Italy

    Contact

  • Università degli studi di Padova

    NOT_YET_RECRUITING

    Padova, 35122, Italy

What this could mean

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

Active substance

Hydra Transcatheter Aortic Valve System (a device implanted via catheter to replace the aortic valve)

What this could lead to

If successful, this could confirm that the Hydra valve is a safe and effective option for treating severe aortic stenosis without open-heart surgery.

What could go wrong

This is an observational study, not a randomized trial, so results may be less definitive. Risks include bleeding, stroke, or valve-related complications, as with any TAVI procedure.

Conditions

The condition(s) this trial relates to.

aortic valve stenosis

As listed by the trial registrant

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