Pediatric Adhesion and New Dermal Approach Study

Launched by IRHYTHM TECHNOLOGIES, INC. · Aug 5, 2025

Keywords

ClinConnect Summary

This study is looking at how well a small, sticky heart monitor called the Zio® monitor works for children aged 1 to 17 years. The device is worn like a band-aid on the upper left chest for up to 14 days and records the child’s heart rhythm and rate. Researchers want to see if the monitor stays stuck to the skin comfortably for the full time and if it provides clear and accurate heart data.

Children who weigh more than 22 pounds and are between 1 and 17 years old may be able to take part, as long as their parent or guardian agrees to help with the study visits. Kids with skin allergies, skin injuries where the monitor would go, or certain heart conditions might not be eligible. If a child joins, they will wear the monitor for up to two weeks while going about their normal activities. This study will help doctors understand if this heart monitor is a good option for kids to wear safely and comfortably for longer periods.

Gender

ALL

Eligibility criteria

• 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.