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New heart valve device tested in tiny early study

NCT ID NCT07116551

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early study is testing a new balloon-expandable heart valve system from Abbott for people with severe, symptomatic aortic stenosis. The valve is delivered through a catheter, avoiding open-heart surgery. Only 11 participants are enrolled to check if the device is safe and works as intended.

What this could mean

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

Active substance
Abbott BE TAVI System (a balloon-expandable heart valve replacement device)
What this could lead to
If successful, this could lead to a new, less invasive option for replacing a narrowed heart valve, potentially improving survival and quality of life for people with severe aortic stenosis.
What could go wrong
This is a very early, small study with only 11 people, so results may not apply to everyone. The device could fail or cause complications like bleeding, stroke, or need for a permanent pacemaker.

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

11 people

The number who actually took part.

Started

Oct 2025

Expected to finish

Jun 2031

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

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Subject is at least 18 years of age * Subject is able and willing to return for required follow-up visits and assessments * Degenerative severe aortic valve stenosis of the native aortic valve with echo-derived criteria Exclusion Criteria: * Pregnant or nursing subjects * Life expectancy for a condition other than aortic stenosis is less than 2 years * Presence of other anatomic or comorbid conditions * Incapacitated individuals * Evidence of an acute myocardial infarction * Untreated clinically significant coronary artery disease requiring revascularization * Liver failure * Severe mitral regurgitation or severe mitral stenosis * etc.

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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.

Symptomatic severe aortic stenosis

Contacts and locations

Locations

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407, United States

  • Clinique Pasteur Toulouse

    Toulouse, Midpyre, 31076, France

  • Columbia University Medical Center/New York-Presbyterian

    New York, New York, 10032, United States

  • Montefiore Medical Center - Moses Division

    The Bronx, New York, 10461, United States

  • Via Christi Regional Medical Center

    Wichita, Kansas, 67214, United States

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