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NCT Number: NCT06382207

Effectiveness of the Eko Digital Stethoscope in Capturing Infant ECGs

When a newborn is diagnosed with tachyarrhythmia, they are generally started on medical therapies, most commonly a beta-blocker, while being observed in an inpatient setting. In most academic institutions, current practice is to provide parental teaching on use of a stethoscope to auscultate their child when there is suspicion for distress, in addition to requiring cardiopulmonary resuscitation (CPR) classes. Fortunately, newer technologies have emerged that allow for capture of cardiac rhythm that may provide a buffer between the infant and the emergency room.

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Key information

Conditions

Tachyarrhythmia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia

Age range

Up to 1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location status: Recruiting

Location contact

Christopher Snyder

CONTACT

[email protected]

Christopher Snyder

PRINCIPAL_INVESTIGATOR

Margaret Lessard

CONTACT

[email protected]

About this study

Tachyarrhythmias which would prompt an emergent call to the pediatric cardiologist following the child, along with simultaneous transportation towards the nearest, preferably pediatric, emergency room. In reality, parental caregivers may be blinded by their personal anxiety in caring for their child with a tachyarrhythmia, and their interpretation or ability to count their child's heart beats may not be accurate. This in turn, can result in unnecessary calls and visits to the emergency room which increase their utilization in addition to piling onto the already astounding cost of healthcare in the United States. Fortunately, newer technologies have emerged that allow for capture of cardiac rhythm that may provide a buffer between the infant and the emergency room. Eko manufactures a digital stethoscope with 1-lead electrocardiogram (ECG), the DUO, which pairs with a mobile application that allows the clinician to further engage with the device during and after a clinical visit. The application enables the clinician to visualize the sounds and electrical signals coming from the device in real time.

Currently, the DUO is cleared for use on patients greater than or equal to 10 kg. This device may have additional clinical utility in pediatric patients <10 kg when used by either a physician or a parent/caregiver at home for remote patient monitoring. The CORE 500 may also have clinical utility in this patient population.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age <1 year
  • No previous diagnosis of arrhythmia
  • Parent/caregiver can provide informed consent
  • Parent/caregiver can speak and understand simple English

Exclusion criteria

  • Age ≥ 1 year
  • Patient has a pacemaker or implantable cardioverter defibrillator (ICD)
  • Parent/caregiver is unwilling or unable to provide informed consent
  • Parent/caregiver is unable to speak and understand English

Treatment and study plan

Eko Duo electronic stethoscope

Device

A digital stethoscope with 1-lead electrocardiogram (ECG), the DUO, which pairs with a mobile application that allows the clinician to further engage with the device during and after a clinical visit. The application enables the clinician to visualize the sounds and electrical signals coming from the device in real time.

CORE 500 electronic stethoscope

Device

The CORE 500 has 3 electrodes that produce a 3 lead ECG, which can be viewed through the Eko app. The CORE 500 also has a user interface screen which provides a number of functions including confirming when all three electrodes have good skin contact, showing a single lead ECG wave, providing heart rate, allowing the user to switch between audio modes, allowing the user to take recordings, and providing AI analysis results for recordings.

Primary outcomes

  1. Number and proportion of good-quality ECG recordings taken by physicians, for DUO and for CORE 500

    Time frame: Baseline Visit

    Number and proportion of good-quality ECG recordings taken by physicians, for DUO and for CORE 500. A "good-quality" ECG recording is defined as one where the tracing is clear enough and with sufficient amplitude to define the p-wave, QRS complex, and t-wave, beyond a reasonable doubt, to allow determination of the patient's cardiac rhythm, by two independent pediatric electrophysiologists and a pediatric cardiologist.

  2. Number and proportion of good-quality ECG recordings taken by parents/caregivers, with a physician present in the exam room using the CORE 500

    Time frame: Baseline Visit

    Number and proportion of good-quality ECG recordings taken by parents/caregivers, with a physician present in the exam room, for CORE 500. A "good-quality" ECG recording is defined as one where the tracing is clear enough and with sufficient amplitude to define the p-wave, QRS complex, and t-wave, beyond a reasonable doubt, to allow determination of the patient's cardiac rhythm, by two independent pediatric electrophysiologists and a pediatric cardiologist.

  3. Number and proportion of good-quality ECG recordings taken by parents/caregivers, with a physician absent from the exam room, for CORE 500

    Time frame: Baseline Visit

    Number and proportion of good-quality ECG recordings taken by parents/caregivers, with a physician absent from the exam room, for CORE 500. A "good-quality" ECG recording is defined as one where the tracing is clear enough and with sufficient amplitude to define the p-wave, QRS complex, and t-wave, beyond a reasonable doubt, to allow determination of the patient's cardiac rhythm, by two independent pediatric electrophysiologists and a pediatric cardiologist.

  4. Number and proportion of good-quality ECG recordings taken by parents/caregivers, at home, for CORE 500 only

    Time frame: At end of study (two weeks)

    Number and proportion of good-quality ECG recordings taken by parents/caregivers, at home, for CORE 500. A "good-quality" ECG recording is defined as one where the tracing is clear enough and with sufficient amplitude to define the p-wave, QRS complex, and t-wave, beyond a reasonable doubt, to allow determination of the patient's cardiac rhythm, by two independent pediatric electrophysiologists and a pediatric cardiologist.

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Snyder

CONTACT

[email protected]

8046284787

Margaret Lessard

CONTACT

[email protected]

804-628-3093

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • Eko Devices, Inc.

Registry information

Official study title

Effectiveness of the Eko Digital Stethoscope in Capturing Infant Electrocardiograms

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 24, 2024
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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