Digital stethoscope and 3-lead ECG detection of pulmonary hypertension and low ejection fraction
Official title: Deep Learning for Detection of Pulmonary Hypertension and Reduced Left Ventricular Ejection Fraction Using a Combined Digital Stethoscope and Three-lead Electrocardiogram
Run by Eko Devices, Inc. · NCT07087613 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 3850 (estimated) |
| Sponsor | Eko Devices, Inc. Industry-sponsored |
| Locations | 4 sites (O'Fallon, Illinois and 3 other locations) |
| Status | Recruiting |
| Started | June 15, 2025 |
| Main results expected | May 31, 2027 |
| Study ends | May 31, 2027 |
| Registry record updated | June 18, 2026 |
| Trial ID | NCT07087613 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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%.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 years and older * Able and willing to provide informed consent * Completed a clinical echocardiogram or right heart catheterization 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 (does not apply to patients undergoing right heart catheterization)
Where it's running
-
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 -
Sentara Norfolk General Hospital
Norfolk, Virginia, United States Recruiting
Study contacts
- Study coordinator: Nicole Sutter
- Email: colie.sutter@ekohealth.com
- Phone: 707-280-7059
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.