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.
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
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Study contacts
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Contact
Phone: •••-•••-•••• Email: •••••@•••••
Locations
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Fondazione Poliambulanza Istituto
RECRUITINGBrescia, 25124, Italy
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IRCCS Ospedale Galeazzi-Sant'Ambrogio
NOT_YET_RECRUITINGMilan, 20157, Italy
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Montevergine Clinic, Mercogliano, Italy
RECRUITINGMercogliano, 83013, Italy
Contact
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Università degli studi di Padova
NOT_YET_RECRUITINGPadova, 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.