Zio Monitor for Pediatric Heart Monitoring

(PANDA Trial)

Recruiting at 3 trial locations

Overseen By Janet Sr. Clinical Research Project Manager

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: iRhythm Technologies, Inc.

Disqualifiers: Adhesive allergies, Skin injury, Cardiac danger, others

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

Compensation: Varies

Number of Visits: 1

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the Zio monitor, a small adhesive patch, to determine if children can comfortably wear it for up to 14 days. The device tracks heart rhythm and rate, aiding in the assessment of heart health. The trial seeks children aged 1 to under 18, weighing more than 22 pounds, without skin allergies or issues at the patch site.

As an unphased trial, participants contribute to advancing heart health monitoring technology for children.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It seems focused on monitoring heart rhythms with a wearable device, so it's best to ask the study team for guidance.

What prior data suggests that the Zio monitor is safe for pediatric heart monitoring?

Research has shown that the Zio monitor is generally safe for adults. This small device, worn on the chest, tracks heart rhythms. However, its safety and effectiveness for children remain unknown. The device should not be used near MRI machines due to its metal parts, which could cause burns. Although the monitor is designed to be worn for several days to collect heart data, further studies are needed to confirm its safety for children. Prospective trial participants should discuss potential risks and benefits with their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Zio monitor is unique because it offers continuous heart rhythm monitoring for up to 14 days, which is particularly beneficial for pediatric patients who may have intermittent symptoms. Traditional methods often involve bulky equipment and shorter monitoring periods, which can miss irregular heart events. Researchers are excited about the Zio monitor because it is a lightweight, discreet device that can be worn comfortably by kids, improving compliance and potentially leading to more accurate diagnoses of heart conditions in this age group.

What evidence suggests that the Zio monitor is effective for pediatric heart monitoring?

Research has shown that the Zio monitor, under study in this trial, effectively checks heart rhythms in children. Studies have found that it can track heart activity for up to 14 days, longer than traditional methods. The Zio patch often detects heart rhythm issues more effectively than older devices like the Holter monitor. In a study comparing the two, the Zio patch discovered more heart rhythm problems. It is also wireless and adheres directly to the chest, making it convenient and less bothersome for children. Overall, the Zio monitor is a reliable tool for monitoring heart rhythms in young patients. ^{5 6 7 8 9}

Who Is on the Research Team?

Charles Berul, MD

Principal Investigator

Children's National Research Institute

Are You a Good Fit for This Trial?

This trial is for children with conditions like congenital heart defects, arrhythmia, fainting, and congenital thymic hypoplasia. It's designed to test if they can wear the Zio monitor device comfortably for up to two weeks.

Inclusion Criteria

Child's legally authorized representative is willing and able to provide informed consent and assist the Child in completing all visits for the study. Assent will be captured if the Child is old enough

The prescribed Zio monitor wear time is planned to be up to 14 days

My child is over 1 year old and weighs more than 22 pounds.

Exclusion Criteria

My child cannot or will not follow the study rules.

The local Investigator deems the Child has a condition that could limit the Child's ability or willingness to participate in the study, or ability to comply with study required procedures and/or follow-up visits. (It is understood that younger age groups of children may present development behavioral challenges in compliance with use of medical devices. Normal development stage should not be considered a reason for exclusion)

My child has skin damage with discharge where the device will be placed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Device Wear

Participants wear the Zio® monitor device to evaluate analyzable time and skin adherence

Up to 14 days

1 visit (in-person) for device application

Follow-up

Participants are monitored for skin irritation and device performance after device removal

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Zio monitor

Trial Overview The study is testing the Zio monitor, a patch-like heart monitor worn on the chest. It checks how well it sticks to skin and records heart rate and rhythm in pediatric patients over a period of up to 14 days.

How Is the Trial Designed?

Group I: Single-arm study to analyzable time for use in pediatric patients up to 14 days Experimental Treatment 1 Intervention

Zio monitor

Who Is Running the Clinical Trial?

iRhythm Technologies, Inc.

Lead Sponsor

Trials

4

Recruited

1,400+

Citations

1. publications.aap.org publications.aap.org/pediatrics/article/144/2_MeetingAbstract/908/3961/Patch-ambulatory-rhythm-monitoring-in-children-a

Patch ambulatory rhythm monitoring in children: a cost- ... This study presents a cost-effectiveness analysis using data collected on 373 Zio studies performed on patients 0-18 years in a pediatric cardiology clinic.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1058981321000825

Patch versus traditional ambulatory ECG monitoring in ... The Zio is a compact and wireless device that directly adheres to the chest and allows for up to 14 days of continuous single-channel rhythm monitoring. The ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03309956

Holter Versus Zio Patch Electrocardiographic Monitoring in ... Demographic data will be collected, including date of birth, age, gender, weight, height, chest circumference, body surface area, indication for ambulatory ECG ...

4. academic.oup.com academic.oup.com/europace/article/25/Supplement_1/euad122.555/7176548

Zio XT for ambulatory heart rhythm monitoring: a cost-benefit ... Data from the 200 Holter and 204 Zio cases was extrapolated to model outcomes for 1 year, assuming 2000 patients undergo ECG monitoring per ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7316129/

Wearable Devices for Ambulatory Cardiac Monitoring The Zio patch has been shown to have a higher diagnostic yield for arrhythmia detection than Holter monitoring (8). An effectiveness study was carried out for ...

6. help.myzio.com help.myzio.com/zio-at-safety.html

MyZio Safety The Zio AT ECG Monitoring System is intended to capture, analyze and report symptomatic and asymptomatic cardiac events and continuous electrocardiogram (ECG) ...

7. irhythmtech.com irhythmtech.com/us/en/patients/patient-support-faq

FAQ Do not expose the Zio monitor to a magnetic resonance imaging (MRI) environment. Thermal injury and burns may occur due to the metal components of the Zio AT ...

8. cincinnatichildrens.org cincinnatichildrens.org/health/h/holter-monitoring

Holter and Zio Monitoring in Children | Medical Examination The monitor is a diagnostic tool used to record the rate and rhythm of the heart. A Zio monitor records the electrical activity of the heart from three to 30 ...

9. irhythmtech.com irhythmtech.com/content/dam/irhythm/united-states/ifus/DLB0035.04%20-%20Zio%20Monitor%20Instructions%20for%20Use.pdf

Instructions for Use Safety and effectiveness of the Zio monitor on pediatric patients (younger than 18 years old) has not been established. • Do not use the Zio monitor on ...