Development of an Algorithm to Differentiate Heart Murmurs Using Electronic Stethoscopes

Completed

Conditions studied: Murmur, Heart, Aortic Valve Stenosis, Tricuspid Regurgitation, Mitral Regurgitation, Innocent Murmurs, Heart Murmurs

In brief

The Eko CORE and DUO stethoscopes are FDA-approved electronic devices that have the capacity to record heart sounds. The study seeks to expand murmur detection to include VHD classification through the development of novel ML algorithms that are able to distinguish between systolic vs. diastolic vs. continuous murmurs, as well as classify VHD type and severity, using 4-point auscultation with Eko CORE and DUO electronic stethoscopes to record heart sounds.

Key facts

Study ID

NCT04400513

Run by

Eko Devices, Inc.

People needed

1145

Starts

2020-06-25

Expected to finish

2021-12-31

Last updated by the study team

2023-02-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged 18 years and older
• Patient or patient's legal healthcare proxy consents to participation
• Have an audible heart murmur in at least one auscultation position, as heard by a clinician
• Undergoing or have undergone a complete (i.e., not limited) echocardiogram
• Willing to have heart recordings done with two different electronic stethoscopes

You may not qualify if…

• Patient or proxy is unwilling or unable to give written informed consent
• Unable to complete a full clinical echocardiogram
• No audible heart murmur in at least one auscultation position, as heard by a clinician
• 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

Where it is running

• CoxHealth — Springfield, Missouri, United States

Full record on ClinicalTrials.gov

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