New heart valve device tested in 500 patients

NCT ID NCT05956652

Recruiting now Disease control Sponsor: Sahajanand Medical Technologies Limited Source: ClinicalTrials.gov ↗

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

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.

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.

aortic valve stenosis

As listed by the trial registrant

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

AORTIC VALVE STENOSIS

Contacts and locations

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
Università degli studi di Padova
NOT_YET_RECRUITING

Padova, 35122, Italy

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