Detecting Pulmonary Hypertension With the Eko CORE 500 Digital Stethoscope (EKO-PH)

Eko Devices

Status: Enrolling

Conditions: Pulmnary Hypertension

Treatments: Diagnostic Test: Digital stethoscope phonocardiogram + three-lead electrocardiogram (Eko CORE 500)

Study type: Observational

Funder types: Industry

Identifiers

NCT07136623

2024.4

Details and patient eligibility

About

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.

Full description

Detailed Description:

This is a prospective, observational, multi-site study to determine whether synchronized heart-sound (phonocardiogram; PCG) and three-lead electrocardiogram (ECG) recordings collected with the FDA-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, AUC, PPV/NPV), including subgroup analyses to evaluate generalizability. 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 IDs. PCG/ECG recordings are transmitted to a HIPAA-compliant, secure server; de-identified demographics, clinical data (e.g., TTE Doppler measures including TR 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 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.

Enrollment: 1,513 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,513 participants in 1 patient group

Outpatient Echo/RHC Patients

Description:

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 + 3-lead ECG) 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.

Treatment:

Diagnostic Test: Digital stethoscope phonocardiogram + three-lead electrocardiogram (Eko CORE 500)