Clinical trial Recruiting at 1 site Observational Ages 18 and up

Detect reduced left ventricular ejection fraction using a three-lead ECG and heart sounds with AI

Official title: Detection of Reduced Left Ventricular Ejection Fraction With Three-Lead ECG Using Artificial Intelligence

Run by Eko Devices, Inc. · NCT07270692 · Data updated 2026-11-12

This will test whether an AI that uses a three-lead ECG and digital stethoscope heart sounds can tell if an adult has an ejection fraction ≤ 40%.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment500 (estimated)
SponsorEko Devices, Inc.
Industry-sponsored
Locations1 site (Mumbai, Maharashtra)
StatusRecruiting
StartedAugust 1, 2025
Main results expectedOctober 2027
Study endsDecember 31, 2027
Registry record updatedNovember 4, 2026
Trial IDNCT07270692 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18 and older who can give informed consent and complete a clinical echocardiogram within seven days before or after the recordings are ideal candidates.

Probably not a fit

Hospitalized patients and those unable to provide informed consent or complete a timely echocardiogram are not eligible and unlikely to benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study trains and evaluates an algorithm to predict an ejection fraction ≤ 40% using inputs from a three-lead ECG and heart sounds captured by Eko digital stethoscopes. Clinical echocardiogram results within seven days of recording serve as the reference standard for left ventricular ejection fraction. The project also examines how algorithm performance varies by age, gender, and race. Participants are adult outpatients able to give consent and undergo the required echocardiogram.

Why it matters

Potential benefit: If successful, the approach could provide a low-cost, noninvasive way to screen adults for reduced ejection fraction earlier and more broadly.

How similar studies have gone: Prior work using AI on standard 12-lead ECGs has shown promise for detecting low ejection fraction, but combining three-lead ECGs with digital stethoscope heart sounds is less tested and more novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • P. D. Hinduja Hospital and Medical Research Centre
    Mumbai, Maharashtra, India
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.