Pediatric Apple Watch Study

N/AEnrolling By InvitationNCT06053372

Stanford University100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

100

Conditions

Arrhythmia in Children

Interventions

Apple WatchDEVICE

Wearable monitor for heart rate and arrhythmia detection

Eligibility

Sex: ALLMin age: 6 YearsMax age: 21 Years

Medical Language ↔ Plain English

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.

Locations (1)

Stanford University

Palo Alto, California, United States

Outcomes

Primary Outcomes

Heart rate correlation

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

Time frame: Up to 2 weeks

Arrhythmia correlation

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

Time frame: Up to 6 months

Data from ClinicalTrials.gov

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