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OpenTrials
Completed

NCT Number: NCT06053372

Pediatric Apple Watch Study

Specific Aim #1 - To determine the accuracy of Apple Watch ECG tracings heart rate in children.

Specific Aim #2 - To determine if extended monitoring with the Apple Watch can identify arrhythmia events that were not detected by short term clinical monitoring.

Completed

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Key information

Age range

6 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Palo Alto, California, 94306, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All pediatric patients age 6 - 21 years undergoing clinically indicated arrhythmia monitoring
  • Patients with developmental ability (as determined by patient and parents) to safely wear the Apple Watch and utilize the patient activated trigger buttons on both the clinical monitor and the Apple Watch.

Exclusion criteria

  • Age < 6 years. Those under 6 many not be able to safely use the watch and have the developmental ability (as gauged by clinician and parents) to utilize the trigger features on the watch and cardiac rhythm monitor.
  • Inability to effectively utilize the triggered features of the monitor or watch
  • Patients unable to utilize the Apple Watch.

Treatment and study plan

Apple Watch

Device

Wearable monitor for heart rate and arrhythmia detection

Primary outcomes

  1. Heart rate correlation

    Time frame: Up to 2 weeks

    Comparison of heart rate (bpm) between the Apple Watch and standard clinical rhythm monitor

  2. Arrhythmia correlation

    Time frame: Up to 6 months

    Comparison of the number of clinically significant arrhythmia events between the Apple Watch and standard clinical rhythm monitor. Clinically significant arrhythmia events include supraventricular arrhythmias, ventricular arrhythmias, sinus pauses, and conduction abnormalities/heart block

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Leveraging Wearable Technologies for Arrhythmia Detection in Children - The PAW (Pediatric Apple Watch) Study

Acronym: PAWS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2023
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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