Digital stethoscope and 3-lead ECG detection of pulmonary hypertension and low ejection fraction
Deep Learning for Detection of Pulmonary Hypertension and Reduced Left Ventricular Ejection Fraction Using a Combined Digital Stethoscope and Three-lead Electrocardiogram
This project will test whether heart sounds and a three-lead ECG recorded with a digital stethoscope can find pulmonary hypertension or low left ventricular ejection fraction in adults having an echocardiogram.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3850 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eko Devices, Inc. Industry-sponsored |
| Locations | 3 sites (O'Fallon, Illinois and 2 other locations) |
| Trial ID | NCT07087613 on ClinicalTrials.gov |
What this trial studies
This prospective, observational protocol enrolls adults undergoing clinically indicated transthoracic echocardiography at outpatient sites. During a single ~20-minute visit, heart sounds (phonocardiograms) and a three-lead ECG will be recorded at four standard auscultation sites using the Eko CORE 500 device, with each recording lasting about 15 seconds and poor-quality recordings repeated once. De-identified 12‑lead ECGs performed within 30 days may be included for comparison. Algorithm outputs from the recorded signals will be compared with echocardiographic findings to determine whether the signals identify pulmonary hypertension or ejection fraction ≤40%.
Who should consider this trial
Good fit: Adults aged 18 or older who can provide informed consent and are scheduled for a clinical transthoracic echocardiogram at one of the participating outpatient sites are the intended participants.
Not a fit: Hospitalized patients, those unable to consent, patients undergoing limited echocardiograms, or individuals who cannot provide usable stethoscope or ECG recordings are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could enable quicker, lower-cost screening for pulmonary hypertension and reduced ejection fraction at the point of care, allowing earlier diagnosis and treatment.
How similar studies have performed: Prior AI work using ECGs and digital auscultation has shown promise for detecting low ejection fraction and some valvular findings, but applying these signals specifically to detect pulmonary hypertension with this device is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 years and older * Able and willing to provide informed consent * Completed a clinical echocardiogram within 7 days before or after study procedures Exclusion Criteria: * Unwilling or unable to provide informed consent * Patients who are hospitalized * Patients undergoing echocardiography with a limited echocardiogram
Where this trial is running
O'Fallon, Illinois and 2 other locations
- Prairie Cardiovascular — O'Fallon, Illinois, United States (Recruiting)
- Prairie Education & Research Cooperative — Springfield, Illinois, United States (Recruiting)
- St Johns Hospital, Springfield — Springfield, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Nicole Sutter
- Email: colie.sutter@ekohealth.com
- Phone: 707-280-7059
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.