Real-World Evaluation of Eko Algorithms in a Point of Care Setting

  • STATUS
    Recruiting
  • End date
    May 23, 2023
  • participants needed
    300
  • sponsor
    Eko Devices, Inc.
Updated on 23 July 2022
diabetes
electrocardiogram
hypertension
stroke
infarct
fibrillation
a 12
Accepts healthy volunteers

Summary

The purpose of this research is to prospectively test and validate the utility of Eko AI plus EMAS murmur characterization algorithm in a real world, point-of-care setting.

Description

Eko has developed a platform to aid in screening for cardiac conditions using a digital stethoscope and machine-learning algorithms to detect the presence or absence of heart conditions such as heart murmurs and atrial fibrillation.

In November 2019, the US Food and Drug Administration (FDA) granted Eko a 510(k) clearance for the marketing of "Eko AI", a set of machine learning algorithms that includes atrial fibrillation (AF) and heart murmur detection. The detection of heart murmurs may aid in detecting occult and dangerous valvular heart disease (VHD). Other Eko AI outputs include bradycardia, tachycardia, noisy signal, QRS duration, and unclassified data. Eko AI has accuracy comparable to physician judgment (atrial fibrillation sensitivity of 98.9% and specificity of 96.9%, murmur sensitivity of 87.6% and specificity of 87.8%). Both AF and VHD can cause significant morbidity and mortality when missed or diagnosed late.

Eko has further developed the murmur detection function of Eko AI to now not only identify whether a murmur is present, but also to inform the clinician of its timing during the cardiac cycle (systole vs diastole), and whether it is innocent or structural. We are calling this product the Eko Murmur Analysis Software (EMAS) and submitted a premarket notification to FDA in December 2021.

This study sets out to understand the utility of the Eko AI plus EMAS murmur characterization algorithm in real world use. Collecting data in a point-of-care setting will demonstrate how accurately the algorithm characterizes murmurs in comparison to an AI-unassisted clinical examination. Algorithm output and clinical determination will be confirmed by echocardiographic ground truth, with the results being blinded until the end of the patient visit.

Details
Condition Murmur, Heart, Innocent Murmurs, Heart Murmurs, Atrial Fibrillation, Pathologic Murmur
Treatment Use of Eko CORE and Eko DUO electronic stethoscope
Clinical Study IdentifierNCT05459545
SponsorEko Devices, Inc.
Last Modified on23 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient consents to participation
Willing to have heart sounds recorded with an electronic stethoscope
Willing to undergo echocardiography
Willing to undergo a 12-lead electrocardiography
Adults aged 50 years and older
Cohort 1 only: history of at least one of the following: hypertension, BMI ≥ 30, diabetes mellitus, hyperlipidemia, atrial fibrillation, myocardial infarction, stroke/TIA, previous coronary surgery, or previous coronary angiography
Cohort 2 only: no history of hypertension, BMI ≥ 30, diabetes mellitus, hyperlipidemia, atrial fibrillation, myocardial infarction, stroke/TIA, previous coronary surgery, or previous coronary angiography
No prior diagnosis of valve disease or heart murmur

Exclusion Criteria

Patient is unwilling or unable to give written informed consent
Investigator discretion based on the best interest of the patient (e.g., experiencing a sudden, acute cardiac event)
Under the age of 50 years old
Prior diagnosis of valve disease or heart murmurs
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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