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AI ultrasound could unmask silent heart disease in seniors

NCT ID NCT07756398

Diagnosis Sponsor: University of Texas Southwestern Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 10, 2026 · Last updated Aug 18, 2026 · Updated 3 times

Summary

This trial tests whether an AI-guided handheld ultrasound, used during routine primary care or geriatrics visits, can detect serious heart valve disease and weak heart muscle in adults aged 65 to 85 who have no known heart problems. Half of the participants will receive this quick ultrasound screening, while the other half gets usual care. The goal is to see if the AI approach leads to more new diagnoses of structural heart disease, which often goes unnoticed until symptoms appear.

What this could mean

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

Active substance
AI-guided point-of-care ultrasound using a handheld device (Kosmos Torso-One)
What this could lead to
If effective, this could make it easier to catch serious heart conditions early in older adults, potentially preventing heart failure and improving outcomes.
What could go wrong
The screening may produce false alarms or miss cases, and the added testing could increase costs. The trial is still testing whether this approach works better than usual care.

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 1,088 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

65 to 85 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: Provider (cluster) participants: * Physician or advanced practice provider (physician assistant or nurse practitioner) practicing in primary care or geriatrics at a participating institution who independently assesses patients * Patient panel comprising \>50% adults aged 65 years or older * Sees patients in ambulatory clinic at least 1 day per week on average * Agrees to participate, to undergo randomization, and to permit inclusion of all eligible patients from the panel * Provides written informed consent Patient participants: * Adults aged 65 to 85 years, inclusive * Attending a scheduled outpatient visit at a participating geriatrics or primary care clinic * Willing and able to provide written informed consent and, if the AI-POCUS screen is positive, to return for a confirmatory echocardiogram Exclusion Criteria: Provider (cluster) participants: * Serving in a locum tenens or other temporary capacity * Unwilling or unable to nominate an AI-POCUS champion from the clinic Patient participants: * Echocardiogram performed within the past 5 years * At least moderate aortic or mitral valve disease, or left ventricular ejection fraction 50% or less, documented on any prior echocardiogram * History of surgical or transcatheter intervention for aortic or mitral valve disease * Self-reported structural heart disease * Significant frailty burden or comorbidities limiting life expectancy to 1 year or less * Unable to provide informed consent

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis heart failure heart valve disorder mitral valve insufficiency Ventricular Dysfunction, Left

As listed by the trial registrant

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

Aortic stenosis Left ventricular diastolic dysfunction Mitral regurgitation Valvular heart disease patients

How to take part

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

  1. The places running it

    2 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

  • Parkland Health

    Dallas, Texas, 75390, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

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