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

Eko Devices

Status: Enrolling

Conditions: Structural Heart Disease

Treatments: Device: Eko digital stethoscopes

Study type: Observational

Funder types: Industry

Identifiers

NCT07202104

2025.1

Details and patient eligibility

About

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.

Enrollment: 125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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