NCT07136623 Detecting Pulmonary Hypertension With the Eko CORE 500 Digital Stethoscope
| NCT ID | NCT07136623 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Eko Devices, Inc. |
| Condition | Pulmnary Hypertension |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,513 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,513 participants in total. It began in 2025-08-01 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 to develop and validate a software algorithm to detect PH and, where possible, stratify severity using noninvasive PCG+ECG signals. These recordings are investigational data acquisitions for algorithm development only; they are not diagnostic procedures and will not be used for clinical decision-making. Primary performance measures are sensitivity and specificity versus echocardiogram and RHC references. No clinical decisions will be based on the investigational algorithm, and no changes to standard care are required. The study plans to enroll up to \~1,513 participants to obtain approximately 1,375 evaluable datasets across multiple outpatient sites.
Eligibility Criteria
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.
Contact & Investigator
Michael Troy, MD
PRINCIPAL INVESTIGATOR
University of California, Los Angeles
Frequently Asked Questions
Who can join the NCT07136623 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pulmnary Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07136623 currently recruiting?
Yes, NCT07136623 is actively recruiting participants. Contact the research team at colie.sutter@ekohealth.com for enrollment information.
Where is the NCT07136623 trial being conducted?
This trial is being conducted at Los Angeles, United States, Durham, United States.
Who is sponsoring the NCT07136623 clinical trial?
NCT07136623 is sponsored by Eko Devices, Inc.. The principal investigator is Michael Troy, MD at University of California, Los Angeles. The trial plans to enroll 1,513 participants.