Improvement of an Algorithm to Detect Structural Heart Murmurs in Adult Patients Using Ele
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 o
| Condition(s) | Structural Heart Disease |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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 pro |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Eko Devices, Inc. |
| Locations | Springfield, Missouri, United States |
| Start date | 2025-09 |
| NCT ID | NCT07202104 |
| Official listing | https://clinicaltrials.gov/study/NCT07202104 |