Pediatric Adhesion and New Dermal Approach Study

NCT07118124 | Active Not Recruiting DMC FDA Device

• 1 other identifier: iRT-001-2025
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

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

Keywords

Pediatrics; PANDA Study; Zio monitor; Children; arrhythmia in children

Outcome Measures

Primary Outcomes (1)

• Performance Objective

  The duration of non-artifact ECG signal as a proportion of the device total wear time will be assessed. The sample proportion with analyzable time \>80% is assumed to be 90%. The performance objective will be met if the lower bound of the 95% confidence interval is at least 75%. Percent analyzable time is defined as the duration of non-artifact ECG signal as a proportion of the device total wear time.

  Up to 14 days

Other Outcomes (1)

• Safety Measures

  From enrollment to the end of the device wear period

Study Arms (1)

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

OTHER

Zio monitor

Device: Zio monitor

Interventions

Zio monitor DEVICE

Evaluate analyzable time of the Zio monitor over the wear duration of up to 14 days in a pediatric population.

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

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child is \<18 years of age and ≥1 year of age and weighing \>10 kg (22 pounds) at the time of device application.
• 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.
• The prescribed Zio monitor wear time is planned to be up to 14 days.

You may not qualify if:

• Child has a known allergy to adhesives or hydrogels or with family history of adhesive skin allergies.
• Child has a visible skin injury or broken skin at location for study device placement.
• Child has skin damage and a discharge of clear fluid or pus at the location for study device placement.
• Child is unable or unwilling to participate or comply with study protocol.
• 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.
• 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.
• Child has a neuro-stimulator, as it may disrupt the quality of ECG data.

Sponsors & Collaborators

• iRhythm Technologies, Inc.: lead

Study Sites (4)

Children's National Hospital

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

Location

St. Luke's Children's Hospital

Boise, Idaho, 83712, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

WashU Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Syncope; Heart Defects, Congenital; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes

Study Officials

• Charles Berul, MD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: August 15, 2025
• Primary Completion: September 30, 2025
• Study Completion: March 1, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)