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AI stethoscope aims to spot silent heart and lung disease

NCT ID NCT07087613

Diagnosis Sponsor: Eko Devices, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether a digital stethoscope, combined with artificial intelligence, can detect two serious conditions: high blood pressure in the lungs (pulmonary hypertension) and a weak heart pump (low ejection fraction). About 3,850 adults will have their heart sounds and a simple 3-lead ECG recorded during a 20-minute session. The AI's findings will be compared to standard tests like echocardiograms to see if it can accurately identify these often-silent conditions, potentially enabling earlier and easier screening.

What this could mean

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

Active substance
Eko CORE 500 digital stethoscope with AI algorithm
What this could lead to
If successful, this could lead to a quick, non-invasive screening tool for pulmonary hypertension and low heart pumping, catching these conditions earlier.
What could go wrong
This is an early observational study, not a treatment trial. The AI may not be accurate enough in real-world settings, and results may not apply to all patients.

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 3,850 people

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

Started

Jun 2025

Expected to finish

May 2027

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

This study will enroll adult patients (18 years and older) who are undergoing clinically indicated transthoracic echocardiography or right heart catheterization. Participants must be able and willing to provide informed consent and must complete a clinical echocardiogram or right heart catheterization within 7 days before or after the study procedures. Patients who are hospitalized, unable or unwilling to provide informed consent, or who are undergoing a limited echocardiogram will be excluded.

Ages

18 years and older

Sex

Anyone

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: * Adults aged 18 years and older * Able and willing to provide informed consent * Completed a clinical echocardiogram or right heart catheterization within 7 days before or after study procedures Exclusion Criteria: * Unwilling or unable to provide informed consent * Patients who are hospitalized * Patients undergoing echocardiography with a limited echocardiogram (does not apply to patients undergoing right heart catheterization)

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Conditions

The condition(s) this trial relates to.

heart failure pulmonary hypertension systolic heart failure

As listed by the trial registrant

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

Heart failure with reduced ejection fraction Hypertension, pulmonary

How to take part

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

  1. The places running it

    4 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

  • Prairie Cardiovascular

    RECRUITING

    O'Fallon, Illinois, 62269, United States

  • Prairie Education & Research Cooperative

    RECRUITING

    Springfield, Illinois, 62769, United States

  • Sentara Norfolk General Hospital

    RECRUITING

    Norfolk, Virginia, 23501, United States

  • St Johns Hospital, Springfield

    RECRUITING

    Springfield, Illinois, 62769, United States

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