Deep Learning for Algorithmic Detection of Pulmonary Hypertension Using a Combined Digital Stethoscope and Three-lead Electrocardiogram

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
United States
California
University of California Los Angeles
RECRUITING
Los Angeles
Contact Information
Primary
Nicole Sutter, MPH
colie.sutter@ekohealth.com
707-280-7059
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2026-08-01
Participants
Target number of participants: 1513
Treatments
Outpatient Echo/RHC Patients
Outpatient Echo/RHC Patients~Adults (≥18) referred for clinically indicated transthoracic echocardiography (TTE) and/or right heart catheterization (RHC). One study visit (\~20 minutes) to obtain ≥4 15-second Eko CORE 500 recordings (phonocardiogram and three-lead electrocardiogram) at standard auscultation sites. No randomization or changes to standard care; investigational algorithm outputs are not used clinically. TTE and/or RHC performed within ±7 days provide reference labels for presence/severity of pulmonary hypertension.
Related Therapeutic Areas
Sponsors
Leads: Eko Devices, Inc.

This content was sourced from clinicaltrials.gov