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AI vs. expert eyes: a new test for heart function measurement

NCT ID NCT07771231

Diagnosis Sponsor: EchoNous 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This trial evaluates an AI-assisted tool that measures the heart's pumping efficiency (ejection fraction) from ultrasound clips. The AI's measurements will be compared to those made by a panel of expert cardiologists to see if they are equally accurate. The study uses previously collected, de-identified heart ultrasound images from 416 participants. If the AI proves reliable, it could offer a faster, more consistent way to assess heart health.

What this could mean

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

Active substance
AI-assisted cardiac ultrasound measurement algorithm (Kosmos PLAX EF)
What this could lead to
If successful, this AI tool could help doctors quickly and consistently measure heart function, potentially improving heart failure diagnosis and monitoring.
What could go wrong
The AI may not match expert accuracy in all cases, and the study uses existing clips, not real-time patients, so results may not fully reflect everyday use.

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

416 people

The number who actually took part.

Started

May 2026

Expected to finish

Sep 2026

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

The study used retrospective datasets from 2 sources: ECHO-004 and PLAX LVEF Data Collection studies. Both datasets comprise fully de-identified, retrospective, echocardiographic, PLAX-view clips acquired using the Kosmos diagnostic ultrasound system. Data collection for the ECHO-004 study was performed at Revival Research Institute (Dearborn, Michigan). PLAX LVEF Data Collection was performed at Memorial Healthcare System (Hollywood, Florida). Source data was collected targeting a balanced representation of demographics and clinical characteristics (including normal and low ejection fraction) to ensure the generalizability of study findings.

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: * All data used in this study must have been collected per 45 CFR § 26, * Data must have been collected per source protocol requirements with no deviation for that data set, * Adequate demographic information available from original study participation (sex, BMI, ethnicity, and race), * PLAX acquisition performed by a qualified echocardiographer using the Kosmos system, and * At least one PLAX clip available. Exclusion Criteria: * Inadequate demographic information corresponding to the available data, and * Non-echocardiographer acquired images.

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Conditions

The condition(s) this trial relates to.

heart failure

As listed by the trial registrant

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

Ejection fraction HEART Heart failure Left ventricular ejection fraction Left ventricular ejection fraction less then or equal to 50PERCENT

Contacts and locations

Locations

  • Memorial Healthcare System

    Hollywood, Florida, 33021, United States

More trials for these conditions

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