Effectiveness of the Eko Digital Stethoscope in Capturing Infant ECGs

NCT06382207 | Recruiting FDA Device

• 1 other identifier: HM20029298
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tachyarrhythmia

Keywords

Infant Tachyarrhythmia; Cardiac Rhythm; Digital Stethoscope

Outcome Measures

Primary Outcomes (4)

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

  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.

  Baseline Visit

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

  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.

  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

  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.

  Baseline Visit

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

  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.

  At end of study (two weeks)

Study Arms (1)

Digital Stethoscopes to measure neonatal tachyarrhythmias

OTHER

Parental caregivers of infant research subjects are trained to use technology (digital stethoscopes) to decrease stress and unnecessary trips to the emergency room.

Device: Eko Duo electronic stethoscope; Device: CORE 500 electronic stethoscope

Interventions

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.

Digital Stethoscopes to measure neonatal tachyarrhythmias

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.

Digital Stethoscopes to measure neonatal tachyarrhythmias

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Eko Devices, Inc.: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

MeSH Terms

Conditions

Tachycardia

Condition Hierarchy (Ancestors)

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

Study Officials

• Christopher Snyder

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Snyder

CONTACT

8046284787; christopher.snyder@vcuhealth.org

Margaret Lessard

CONTACT

804-628-3093; margaret.lessard@vcuhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This proof-of-concept study will enroll infants, defined as individuals \<1 year of age. It will assess the feasibility and effectiveness of a physician and parent/caregiver in using the Eko DUO and CORE 500 to capture ECGs in patients \<10 kg in a clinic and home setting.

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 24, 2024
• Study Start: January 17, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

US (1)