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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eko digital stethoscopes | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 15-16 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Associate | Contact | 8443563384 | jackrin.walsh@ekohealth.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| P. D. Hinduja Hospital and Medical Research Centre | Recruiting | Mumbai | Maharashtra | 400016 | India |
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