NCT07136623

Detecting Pulmonary Hypertension With the Eko CORE 500 Digital Stethoscope

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,513 (estimated)
• Sponsor: Eko Devices, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a prospective, observational, multi-site study to determine 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 FDA (U.S. Food and Drug Administration)-cleared Eko CORE 500 digital stethoscope can assist in screening for pulmonary hypertension (PH). Adults (≥18 years) referred for clinically indicated transthoracic echocardiography (TTE) and/or right heart catheterization (RHC) will complete a single study visit (\~20 minutes). During the visit, trained staff will obtain at least four 15-second CORE 500 recordings from standard auscultation locations (aortic, pulmonic, tricuspid, and mitral). The clinical TTE (and RHC, if performed) completed within ±7 days of the recordings will provide reference labels for the presence and severity of PH. If available, de-identified results from a clinical 12-lead ECG performed within 30 days of the TTE may also be abstracted for comparison. The primary objective is to develop and validate a software algorithm that detects PH from PCG+ECG signals; secondary objectives include assessing severity stratification and overall diagnostic performance (e.g., sensitivity/specificity, area under the receiver operating characteristic curve \[AUC\], positive predictive value \[PPV\], negative predictive value \[NPV\]), including subgroup analyses to evaluate generalizability. These recordings are investigational data acquisitions for algorithm development and detection research only; they are not diagnostic procedures and will not be used for clinical decision-making. The study plans to enroll up to \~1,513 participants to obtain approximately 1,375 evaluable datasets (about 1,250 with TTE and 125 with RHC). No clinical decisions will be based on investigational algorithm outputs, and participation does not alter standard care. Key eligibility includes adults able to consent who have a clinical TTE or RHC within the protocol window; exclusions include current hospitalization and limited TTE studies. All study data are de-identified using site-maintained key-coded identification codes (IDs). PCG/ECG recordings are transmitted to a HIPAA (Health Insurance Portability and Accountability Act)-compliant, secure server; de-identified demographics, clinical data (e.g., TTE Doppler measures including TR \[tricuspid regurgitation\] velocity and estimated pulmonary artery systolic pressure, RHC hemodynamics), and relevant reports/images may be abstracted/uploaded per site procedures. This minimal-risk study has IRB (Institutional Review Board) approval. No independent data monitoring committee is appointed; safety oversight is provided by site investigators with adverse event reporting per IRB policy. There is no cost to participants; modest compensation (≤$50, site-specific) may be provided. The CORE 500 hardware is FDA-cleared; however, the software algorithm evaluated in this study is investigational (not FDA-cleared). The aim is regulatory readiness for potential future submission without committing to a specific regulatory filing as part of this study.

Conditions

• Pulmnary Hypertension

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Eko CORE 500 phonocardiogram (PCG) recording	Noninvasive acquisition of heart sound (phonocardiogram, PCG) recordings using the FDA (U.S. Food and Drug Administration)-cleared Eko CORE 500 digital stethoscope. At least four 15-second recordings are collected at standard auscultation sites (aortic, pulmonic, tricuspid, mitral). Recordings are used solely for investigational algorithm development and are not used for diagnostic or clinical decision-making.
DIAGNOSTIC_TEST	Eko CORE 500 three-lead electrocardiogram (ECG) recording	Noninvasive acquisition of three-lead electrocardiogram (ECG) signals using the FDA-cleared Eko CORE 500 digital stethoscope. Recordings are obtained simultaneously with PCG at auscultation sites. Data are used solely for investigational algorithm development and are not intended for diagnostic use.

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2025-08-22
• Last updated: 2026-01-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study