Digital Stethoscope for Rapid Heartbeat in Infants

Overseen By Christopher Snyder

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Must be taking: Beta-blockers

Disqualifiers: Age ≥ 1 year, Pacemaker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new digital stethoscopes, including the CORE 500 and Eko Duo electronic stethoscopes, to assist parents in monitoring newborns diagnosed with tachyarrhythmia, a rapid heartbeat condition. The researchers aim to determine if these devices can reduce stress and unnecessary hospital visits by enabling parents to check their baby's heart rhythm at home. Parents of infants under one year old, without a history of heart rhythm issues, and who can communicate in simple English might be suitable for this trial. As an unphased trial, this study allows parents to contribute to innovative research that could enhance home care for newborns.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these digital stethoscopes are safe for infants?

Studies have shown that both the CORE 500 and Eko Duo electronic stethoscopes are safe for people. The CORE 500 is approved for patient use and can take ECG (electrocardiogram) readings to track heart activity. Research indicates it provides accurate heart rate information without safety issues. The Eko Duo stethoscope is approved for use on children weighing over 10 kg, making it safe for most infants. It effectively captures heart rhythms, aiding in heart condition monitoring without known side effects. Both devices have been used in other settings and have demonstrated safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional stethoscopes, which rely on a clinician's ear to detect heart issues, digital stethoscopes like the CORE 500 and Eko Duo use advanced technology to provide precise, real-time data on an infant’s heartbeat. Researchers are excited about these devices because they empower parents to monitor their baby's heart health at home, potentially reducing stress and trips to the ER. This approach not only makes it easier to detect rapid heartbeats, called tachyarrhythmias, but also offers a more accessible way for families to manage their infant's health with confidence.

What evidence suggests that these digital stethoscopes are effective for measuring neonatal tachyarrhythmias?

Research has shown that the CORE 500 and Eko Duo electronic stethoscopes, evaluated in this trial, effectively capture the heart's electrical activity in babies. These devices can record ECGs for babies weighing less than 10 kilograms, which is crucial for assessing heart health. Studies have found that digital stethoscopes provide more accuracy than traditional methods, such as using a regular stethoscope or manually checking the pulse. They also deliver faster results, aiding in quick assessments. This technology can enhance remote monitoring, reducing unnecessary hospital visits for babies with rapid heartbeats. ^{2 3 6 7 8}

Who Is on the Research Team?

Christopher Snyder

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for infants under 1 year old with rapid heartbeat conditions, where parents can give consent and understand simple English. Infants with a pacemaker or ICD, or whose caregivers cannot consent or understand English are excluded.

Inclusion Criteria

I am under 1 year old.

Parent/caregiver can speak and understand simple English

Parent/caregiver can provide informed consent

Exclusion Criteria

Patient has a pacemaker or implantable cardioverter defibrillator (ICD)

Parent/caregiver is unwilling or unable to provide informed consent

I am at least 1 year old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Training

Parental caregivers are trained to use digital stethoscopes to measure neonatal tachyarrhythmias

1 week

1 visit (in-person)

Baseline Assessment

Good-quality ECG recordings are taken by parents/caregivers with and without a physician present

1 week

2 visits (in-person)

Home Monitoring

Parents/caregivers take ECG recordings at home using the CORE 500 device

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after home monitoring

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CORE 500 electronic stethoscope
• Eko Duo electronic stethoscope

Trial Overview The study tests two electronic stethoscopes (Eko Duo and CORE 500) to see if they're effective in capturing the heart's electrical activity in babies with fast heart rates, potentially reducing ER visits.

How Is the Trial Designed?

Group I: Digital Stethoscopes to measure neonatal tachyarrhythmias Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Eko Devices, Inc.

Industry Sponsor

Trials

14

Recruited

8,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06382207

Effectiveness of the Eko Digital Stethoscope in Capturing ... 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 ...

2. withpower.com withpower.com/trial/phase-tachyarrhythmias-4-2024-31a30

Digital Stethoscope for Rapid Heartbeat in Infants Trial Overview The study tests two electronic stethoscopes (Eko Duo and CORE 500) to see if they're effective in capturing the heart's electrical activity in ...

3. ekohealth.com ekohealth.com/products/core-500-digital-stethoscope?srsltid=AfmBOoqlQRlTPVglAa7QgWj7YRKmS2xqLt9Lu0s8Gaq5sX-IoDlY8AzK

Eko CORE 500™ Digital Stethoscope The CORE 500™ is the modern stethoscope replacement, combining 3-lead ECG, unmatched audio clarity, and waveform visualizations, with available Eko+ ...

4. ekohealth.com ekohealth.com/blogs/newsroom/eko-health-launches-core-500-digital-stethoscope-with-heart-disease-detection-ai-3-lead-ecg-and-advanced-audio-capabilities?srsltid=AfmBOorkovI8H36qqSrkS6raIuanbqItWF7ICk41oWffqTvmshpa6PjA

Eko Health | New Product: CORE 500™ Digital Stethoscope The CORE 500™ is the first stethoscope to provide HCPs with accurate, instantaneous patient auscultation data on a full-color display, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10580137/

Evaluating a Novel Infant Heart Rate Detector for Neonatal ... In neonates, DS used for HR measurement is more accurate than auscultation or pulse palpation and faster than PO in “time to first HR display”; ...

6. ekohealth.com ekohealth.com/products/core-500-digital-stethoscope?srsltid=AfmBOoqECqE27Rnosviqbxa1U4rnlIWxFWzN64kacfOj1ktaDVUkCxzV

Eko CORE 500™ Digital Stethoscope The CORE 500™ is the modern stethoscope replacement, combining 3-lead ECG, unmatched audio clarity, and waveform visualizations, with available Eko+ ...

7. support.ekohealth.com support.ekohealth.com/hc/en-us/articles/16698084427547-CORE-500-FAQ

CORE 500™ FAQ - Eko Help Center While the CORE 500™'s clinical performance and safety are cleared for human patients, it can also be safely used on animals under the use of ...

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K233609.pdf

March 28, 2024 Eko Health, Inc. Sam Huang Director of ... The CORE 500 Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed ...