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New heart valve device tested in 500 patients

NCT ID NCT05956652

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times

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.

Study facts

What this study's own registry entry says, in plain language.

Started

Jul 2023

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patient with severe aortic valve stenosis

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with severe symptomatic native aortic valve stenosis and candidates for the TAVI procedure based on the evaluation of the Heart Team * Ability to understand and provide informed consent for inclusion in the study Exclusion Criteria: * Contraindication to TAVI: e.g. evidence of intracardiac mass, thrombus or vegetation, endocarditis. * Refusal by the patient to participate in the study * High probability of non-adherence to required follow-ups

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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

    Brescia, 25124, Italy

  • IRCCS Ospedale Galeazzi-Sant'Ambrogio

    Milan, 20157, Italy

  • Montevergine Clinic, Mercogliano, Italy

    Mercogliano, 83013, Italy

  • Università degli studi di Padova

    Padova, 35122, Italy

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