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

Recruiting

• Conditions: Structural Heart Disease

• Registration Number: NCT07202104
• Lead Sponsor: Eko Devices, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted: 2025-09-23
• Study First Submitted QC: 2025-09-23
• Last Update Submitted: 2025-09-23
• Study First Posted: 2025-10-01
• Last Update Posted: 2025-10-01
• Primary Completion: 2026-02
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome	6 months	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.

Trial Locations

Locations (1)

Cox Medical Centers; 🇺🇸 Springfield, Missouri, United States