Recruiting NCT07270692

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

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Trial Parameters

Condition Low Ejection Fraction

Sponsor Eko Devices, Inc.

Study Type OBSERVATIONAL

Phase N/A

Enrollment 500

Sex ALL

Min Age 18 Years

Max Age N/A

Start Date 2025-08-01

Completion 2026-08-01

Interventions

Eko digital stethoscopes

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Brief 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 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

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