Pediatric Adhesion and New Dermal Approach Study (PANDA)

iRhythm Technologies

Status: Not yet enrolling

Conditions: Congenital Athymia; Arrhythmia in Children; Arrhythmia; Syncope; Congenital Heart Disease; Pediatric

Treatments: Device: Zio monitor

Study type: Interventional

Funder types: Industry

Identifiers

NCT07118124

iRT-001-2025

Details and patient eligibility

About

The purpose of this study is to see if the Zio® monitor device can be worn by children for up to 14-days and to determine if the skin preparation process will provide good adherence to the skin and clear signal quality. The Zio® monitor (Study Device) is an adhesive patch that is worn on the upper left chest for a specified period of time and is similar to a band aid. The Study Device contains a battery-powered heart monitor and will look at the heart rhythm and rate.

Full description

This is a prospective single-arm study to demonstrate adequate analyzable time for use in pediatric patients up to 14 days of device wear. The study will incorporate a simplified skin preparation procedure. The objective is to evaluate analyzable time of the Zio® monitor device over the wear duration (up to 14 days) in a population 1 to 17 years of age. The study will incorporate a simplified skin preparation procedure.

Enrollment: 36 estimated patients

Sex: All

Ages: 1 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Child is <18 years of age and ≥1 year of age and weighing >10 kg (22 pounds) at the time of device application.
2. Child's legally authorized representative is willing and able to provide informed consent and be able to assist the Child in completing all visits for the study. If the Child is old enough to provide assent, it will also be captured.
3. The prescribed Zio monitor wear time is planned to be up to 14 days.

Exclusion criteria

1. Child has a known allergy to adhesives or hydrogels or with family history of adhesive skin allergies.
2. Child has a visible skin injury or broken skin at location for study device placement.
3. Child has skin damage and a discharge of clear fluid or pus at the location for study device placement.
4. Child is unable or unwilling to participate or comply with study protocol.
5. 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).
6. The child has experienced symptomatic episodes where instance variations in cardiac performance could result in immediate danger to the child or when real-time or in-patient monitoring should be prescribed.
7. Child has an external or wearable cardiac defibrillator or may be exposed to high frequency surgical equipment near strong magnetic fields or devices such as MRI during the wear period.
8. Child has a neuro-stimulator, as it may disrupt the quality of ECG data.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

36 participants in 1 patient group

Single-arm study to analyzable time for use in pediatric patients up to 14 days

Other group

Description:

Zio monitor

Treatment:

Device: Zio monitor