Structural Heart Disease
Conditions
Keywords
structural heart disease, structural murmur
Brief summary
The main objective of this study is to evaluate a machine learning model's ability to detect murmurs indicative of structural heart disease ("structural murmur") by analyzing phonocardiogram waveforms-and simultaneous electrocardiogram waveforms when available-in multiple auscultatory positions per subject. Diagnosis of structural murmur will be confirmed by gold-standard echocardiography and reviewed by an expert panel of cardiologists.
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.
Sponsors
Eko Devices, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18+ years old * Patient or patient's legal healthcare proxy consents to participation * Documented history of SHD * Undergoing (or has undergone, within 30 days) a complete echocardiogram * Willing to have heart recordings done with two different electronic stethoscopes
Exclusion criteria
* Patient or proxy is unwilling/unable to give written informed consent * Unable to complete a complete echocardiogram, or none recent completed within the last 30 days * No documented history of SHD * Experiencing a known or suspected acute cardiac event * Mechanical ventricular support (such as ECMO, LVAD, RVAD, BiVAD, Impella, intra-aortic balloon pumps, TAH, VentrAssist, DuraHeart, HVAD, EVAHEART LVAS, HeartMate, Jarvik 2000) * Unwilling or unable to follow or complete study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary outcome | 6 months | Evaluate a machine learning model's ability to detect murmurs indicative of structural heart disease ("structural murmur") by analyzing phonocardiogram waveforms-and simultaneous electrocardiogram waveforms when available-in multiple auscultatory positions per subject. Diagnosis of structural murmur will be confirmed by gold-standard echocardiography and review by an expert panel of cardiologists. |
Countries
United States
Outcome results
None listed