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New heart valve tested in japanese patients: a step forward for aortic stenosis treatment?

NCT ID NCT07193888

Disease control Sponsor: Abbott Medical Devices Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study is testing the Navitor heart valve, a device used to replace a narrowed aortic valve without open-heart surgery. It will include 100 people in Japan with severe aortic stenosis. Researchers will check how many patients die within 30 days and whether the valve leaks after the procedure.

What this could mean

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

Active substance
Navitor Transcatheter Aortic Valve Implantation (TAVI) device
What this could lead to
If successful, this study could confirm that the Navitor valve works well and safely in everyday practice, supporting its use for treating severe aortic stenosis.
What could go wrong
This is a post-market study with only 100 participants, so results may not apply to all patients. Risks include death within 30 days or valve leakage.

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.

Participants

About 100 people

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

Started

Oct 2025

Expected to finish

Aug 2028

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

Patients with symptomatic, severe aortic stenosis.

Ages

18 to 100 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: 1. Patient is eligible per the current approved indication after Heart Team discussion and intended to undergo a Navitor TAVI procedure. 2. The patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the EC of the respective clinical site. 3. The patient and the treating physician agree that the subject will return for all required post-procedure follow-up visits Exclusion Criteria: 1. Patient is not eligible for the Navitor TAVI System per the current Instructions for Use (IFU). 2. Life expectancy \< 12 months from the time of informed consent due to non-cardiac co-morbid conditions. 3. In the judgment of the Investigator, patient presents with a medical, social, or psychological condition that could limit the ability or willingness to participate in the study, comply with study required testing and/or follow-up visits or that could impact scientific integrity of the study. 4. Known contraindication for computed tomography (CT) or sensitivity to contrast media, which cannot be adequately premedicated. 5. Inability to tolerate antiplatelet/anticoagulation therapy or nitinol alloy (nickel and titanium), which cannot be adequately premedicated. 6. Currently participating in an investigational drug or device study that may confound the results of this study. 7. Anatomy that makes insertion and endovascular access to the aortic valve difficult and/or impossible.

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis cardiovascular disorder

As listed by the trial registrant

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

Severe aortic stenosis

How to take part

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

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • Kokura Memorial Hospital

    RECRUITING

    Fukuoka, Japan

  • Osaka Keisatsu Hospital

    RECRUITING

    Osaka, Japan

  • Shonan Kamakura General Hospital

    RECRUITING

    Kanagawa, Japan

More trials for these conditions

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