Brief Summary: This prospective, observational study will evaluate whether synchronized heart sound (phonocardiogram, PCG) and three-lead electrocardiogram (ECG) recordings collected with the Eko CORE 500 can help screen for pulmonary hypertension (PH). Adults (≥18 years) undergoing clinically indicated transthoracic echocardiography 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. 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.
Brief Summary: This prospective, observational study will evaluate whether synchronized heart sound (phonocardiogram, PCG) and three-lead electrocardiogram (ECG) recordings collected with the Eko CORE 500 can help screen for pulmonary hypertension (PH). Adults (≥18 years) undergoing clinically indicated transthoracic echocardiography 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. 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.
Detecting Pulmonary Hypertension With the Eko CORE 500 Digital Stethoscope
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University of California Los Angeles, Los Angeles, California, United States, 90095
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
18 Years to
ALL
Yes
Eko Devices, Inc.,
Michael Troy, MD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles
2026-08-01