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Can kids wear a heart patch for 14 days? study says yes!

NCT ID NCT07118124

Knowledge-focused Sponsor: iRhythm Technologies, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a small, band-aid-like heart monitor (Zio patch) can be worn by children for up to 14 days. It involved 36 kids aged 1 to 17 years. The goal was to see if the patch sticks well and gives clear heart signals. The study did not test any treatment, only the device's performance.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

36 people

The number who actually took part.

Started

Aug 2025

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac cardiac rhythm disease congenital heart disease Nezelof syndrome Syncope syncope, familial vasovagal

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arrhythmia Arrhythmia in children Congenital athymia Congenital heart disease Pediatric Syncope

Contacts and locations

Locations

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Children's National Hospital

    Washington D.C., District of Columbia, 20010, United States

  • St. Luke's Children's Hospital

    Boise, Idaho, 83712, United States

  • WashU Medicine

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.