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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEko Devices, Inc.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Potential research subjects will be screened for eligibility from cardiology clinics, echocardiogram clinics, and inpatient areas. In order to be eligible, a patient must be 18+ years of age, have a documented history of structural heart disease, and has undergone an echocardiogram within the last 30 days. If a patient meets all of the specified inclusion criteria, and none of the specified exclusion criteria, the patient or their proxy will be approached to discuss participation in the study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Primary outcome

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.

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.