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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEko Devices, Inc.

About this trial

The main objectives of this study are to train and evaluate an algorithm that predicts whether an individual has an ejection fraction ≤ 40%, using heart sounds and a 3-lead ECG as inputs, as well as determine the impact of gender, age, and race on algorithm performance.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Unwilling or unable to provide informed consent

Patients who are hospitalized

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Eko digital stethoscopes

    Device

    Use of the Eko CORE 500 digital stethoscope and 3M Littmann CORE Digital Stethoscope to auscultate and record cardiac phonocardiogram and (when available) electrocardiogram waveforms, as well as heart sounds.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Primary Objective: Collection of Heart Sounds and 3-lead ECG Recordings to Train Algorithm

The primary objective of this study is to train and evaluate an algorithm that predicts whether an individual has an ejection fraction ≤ 40%, by using Eko CORE 500 digital stethoscopes to collect the heart sounds and 3-lead ECG recordings of 500 patients who are 18 years or older and have completed an echocardiogram within 7 days of the study procedures.

Time frame
15-16 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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