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A new heart valve without Open-Heart surgery: can it help High-Risk patients?

NCT ID NCT07734025

Disease control Sponsor: Onecrea Medical Inc. 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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This trial is testing a new device called the Crea Aortic Valve, a replacement heart valve that can be implanted through a catheter without open-heart surgery. It is designed for people aged 60 and older with severe aortic stenosis—a narrowing of the heart's main valve—who are considered too high-risk for traditional surgery. The study will measure how safely and effectively the valve works, and whether it improves patients' symptoms 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
an investigational transcatheter aortic valve replacement system called the Crea Aortic Valve
What this could lead to
If successful, this could offer a new, less invasive option for replacing a narrowed aortic heart valve in patients who are too frail for open-heart surgery.
What could go wrong
This is an early-stage study with only 30 participants, so results may not apply to everyone. As with any heart valve procedure, risks include stroke, bleeding, and valve dysfunction.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Jun 2033

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.

Ages

60 to 80 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: * Age 60 years or older. * Symptomatic severe native calcific aortic valve stenosis. * Considered appropriate for transcatheter aortic valve replacement (TAVR) by the local Heart Team. * Considered at high surgical risk for surgical aortic valve replacement. * Able to understand the study requirements and provide written informed consent. * Willing and able to comply with all study procedures and follow-up visits. Exclusion Criteria: * Contraindication to transcatheter aortic valve replacement or the investigational procedure. * Active infection or endocarditis. * Life expectancy less than one year due to non-cardiac comorbidities. * Participation in another investigational study that could interfere with the objectives of this study. * Any medical, anatomical, or clinical condition that, in the opinion of the investigator or Heart Team, would make study participation inappropriate or place the subject at unacceptable risk.

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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 Severe aortic stenosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.