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Clinical Trials/NCT06053372
NCT06053372
Enrolling By Invitation
Not Applicable

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

Stanford University1 site in 1 country100 target enrollmentAugust 16, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arrhythmia in Children
Sponsor
Stanford University
Enrollment
100
Locations
1
Primary Endpoint
Heart rate correlation
Status
Enrolling By Invitation
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 16, 2024
End Date
March 2026
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Scott Ceresnak

Professor of Pediatrics

Stanford University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Heart rate correlation

Time Frame: Up to 2 weeks

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

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

Study Sites (1)

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