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

Part of paid clinical trials in Springfield, Missouri.

Sponsor
Eko Devices, Inc.
Study ID
NCT07202104
Status
Recruiting

Conditions

  • Structural Heart Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Sep 30, 2025
Status verified
Sep 2025
Primary completion
Feb 28, 2026
Completion
May 31, 2026

Study Design

Enrollment
125 participants (estimated)

Primary Outcome Measure

Primary outcome [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cox Medical CentersSpringfieldMissouri65807
Principal Investigator
(417) 875-2626

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