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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Eko digital stethoscopes
DeviceUse 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
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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