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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 1 visit
  • Procedures mentioned: Heart tracing (ECG)

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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)."
  • "The primary objective is to develop and validate a software algorithm to detect PH and, where possible, stratify severity using noninvasive PCG+ECG signals."
  • "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."
  • "If available, de-identified results from a clinical 12-lead ECG performed within 30 days of the TTE may also be abstracted for comparison."
  • "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."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether heart sounds and heart electrical signals recorded with the Eko CORE 500 digital stethoscope can help detect high blood pressure in the lungs. It is for adults having a heart ultrasound or a test using a thin tube to measure pressure inside the heart. The study takes one visit of about 20 minutes, and the recordings will not guide medical care.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • You can and are willing to give informed consent, meaning you understand and agree to join the study.
  • You have a heart ultrasound through the chest or a right heart catheter test scheduled or done within 7 days before or after the study recording visit. The catheter test uses a thin tube to measure pressure inside the heart.

Who can't join

  • You cannot or do not want to give informed consent.
  • You are in the hospital when the study procedures take place.
  • If you join through the heart ultrasound option, your ultrasound is limited and cannot be used to make a diagnosis.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (2)

CA

NC