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Detecting Pulmonary Hypertension With the Eko CORE 500 Digital Stethoscope

Recruitingn/aAges 18 Years - anyAllEko Devices, Inc.
NCT07136623 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This prospective, observational study will evaluate whether synchronized heart sound (phonocardiogram, PCG) and three-lead electrocardiogram (ECG) recordings (entered as separate interventions in PRS, though collected together in practice) collected with the Eko CORE 500 can help screen for pulmonary hypertension (PH). Adults (≥18 years) undergoing clinically indicated transthoracic echocardiography (TTE) and/or right heart catheterization (RHC) will complete one study visit (\~20 minutes). During the visit, study staff will obtain at least four 15-second CORE 500 recordings (aortic, pulmonic, tricuspid, and mitral areas). The clinical echocardiogram (and RHC, if performed) within ±7 days of the recordings will provide reference labels for the presence and severity of PH; de-identified demographic and clinical data may also be abstracted from the medical record. The primary objective is

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📋 Eligibility rules (as published)
Inclusion Criteria: Age ≥ 18 years. Able and willing to provide informed consent. Clinically indicated transthoracic echocardiogram (TTE) or right heart catheterization (RHC) scheduled/performed within ±7 days of the study recording visit. Exclusion Criteria: Unwilling or unable to provide informed consent. Currently hospitalized at the time of study procedures. If enrolled via TTE path: limited (non-diagnostic) echocardiogram.
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What it tests

  • Eko CORE 500 phonocardiogram (PCG) recording
  • Eko CORE 500 three-lead electrocardiogram (ECG) recording
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Where

2 sites
University of California Los Angeles
Los Angeles, United States
Duke University
Durham, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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