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AI-Powered stethoscope could spot hidden heart trouble in minutes

NCT ID NCT07270692

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 04, 2026 · Updated 5 times

Summary

This study is testing whether an artificial intelligence program can detect low heart function (ejection fraction ≤40%) using heart sounds and a 3-lead ECG recorded with a digital stethoscope. Researchers will collect recordings from 500 adults who have recently had an echocardiogram. The goal is to train the AI to identify people with reduced heart function, which could lead to faster and easier screening in the future.

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 and 3M Littmann CORE Digital Stethoscope
What this could lead to
If successful, this could lead to a simple, quick way to screen for low heart function using a stethoscope and AI, potentially catching heart problems earlier.
What could go wrong
This is an early-stage study to train an algorithm, not a treatment trial. The AI may not be accurate enough in real-world settings or across different groups.

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 500 people

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

Started

Aug 2025

Expected to finish

Nov 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 will employ an all-comers strategy, indicating that virtually any patient who receives a standard-of-care echocardiogram may participate. The echocardiogram must be within 7 days of the CORE 500 measurements to ensure that the measured ejection fraction is contemporaneous with the heart sounds and 3-lead ECG. This will include both healthy patients and patients with low EF.

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: * Adults aged 18 years and older * Able and willing to provide informed consent * Complete a clinical echocardiogram within 7 days before or after study procedures Exclusion Criteria: * Unwilling or unable to provide informed consent * Patients who are hospitalized

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As listed by the trial registrant

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

Low ejection fraction

How to take part

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

  1. The places running it

    1 site. 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

  • P. D. Hinduja Hospital and Medical Research Centre

    RECRUITING

    Mumbai, Maharashtra, 400016, India

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