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

NCT ID: NCT07202104

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-30

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Structural Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Eko 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eko Devices, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cox Medical Centers

Springfield, Missouri, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Clinical Research Associate

Role: CONTACT

8443563384

Facility Contacts

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Principal Investigator

Role: primary

(417) 875-2626

Other Identifiers

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2025.1

Identifier Type: -

Identifier Source: org_study_id

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