RecruitingNCT07270692

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


Sponsor

Eko Devices, Inc.

Enrollment

500 participants

Start Date

Aug 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria2

  • Unwilling or unable to provide informed consent
  • Patients who are hospitalized

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Interventions

DEVICEEko digital stethoscopes

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.


Locations(1)

P. D. Hinduja Hospital and Medical Research Centre

Mumbai, Maharashtra, India

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NCT07270692