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Improvement of an Algorithm to Detect Structural Heart Murmurs in Adult Patients Using Electronic Stethoscopes

RECRUITINGSponsored by Eko Devices, Inc.
Actively Recruiting
SponsorEko Devices, Inc.
Started2025-09
Est. completion2026-02
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

Heart DiseaseStructural Heart Disease

Locations1 site

Cox Medical Centers
Springfield, Missouri, 65807
Principal Investigator(417) 875-2626Christopher.Schulze@coxhealth.com

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