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)
View Full Details on ClinicalTrials.gov
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NCT07270692