Improving an algorithm to detect structural heart murmurs with electronic stethoscopes.
Improvement of an Algorithm to Detect Structural Heart Murmurs in Adult Patients Using Electronic Stethoscopes
This study will test whether a computer algorithm using electronic stethoscopes can detect structural heart murmurs in adults with known structural heart disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 125 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eko Devices, Inc. Industry-sponsored |
| Locations | 1 site (Springfield, Missouri) |
| Trial ID | NCT07202104 on ClinicalTrials.gov |
What this trial studies
This observational study collects heart sound (phonocardiogram) recordings—and simultaneous ECG when available—from multiple auscultation positions using Eko digital stethoscopes. Recordings from adults with documented structural heart disease who have a recent complete echocardiogram (within 30 days) will be paired with gold-standard echo diagnoses and reviewed by an expert cardiology panel. The collected data will be used to improve a machine-learning model's ability to recognize murmurs that indicate structural heart disease. Participants will have recordings taken with two different electronic stethoscopes to build robust, device-diverse training data.
Who should consider this trial
Good fit: Adults 18 or older with a documented history of structural heart disease who are willing to have heart recordings with two electronic stethoscopes and have (or recently had) a complete echocardiogram are ideal candidates.
Not a fit: Patients without documented structural heart disease, those experiencing an acute cardiac event, patients on mechanical ventricular support, or anyone without a recent complete echocardiogram or the ability to consent are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the algorithm could help clinicians detect structural heart murmurs more accurately and noninvasively, enabling faster diagnosis and appropriate referral for echocardiography.
How similar studies have performed: Similar machine-learning approaches using digital stethoscopes have shown promising but variable results in detecting murmurs and valvular disease, and this study builds on that prior work.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Springfield, Missouri
- Cox Medical Centers — Springfield, Missouri, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Research Associate
- Email: jackrin.walsh@ekohealth.com
- Phone: 8443563384
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.