NCT06053372

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 25, 2023

Completed
11 months until next milestone

Study Start

First participant enrolled

August 16, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

12 months

First QC Date

September 14, 2023

Last Update Submit

August 19, 2024

Conditions

Arrhythmia in Children

Outcome Measures

Primary Outcomes (2)

  • Heart rate correlation

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

    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

    Up to 6 months

Study Arms (1)

Apple Watch

EXPERIMENTAL

Participants will wear an Apple Watch for 6 months

Device: Apple Watch

Interventions

Apple WatchDEVICE

Wearable monitor for heart rate and arrhythmia detection

Apple Watch

Eligibility Criteria

Age6 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Palo Alto, California, 94306, United States

Location

Study Officials

  • Scott Ceresnak, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

September 14, 2023

First Posted

September 25, 2023

Study Start

August 16, 2024

Primary Completion

August 1, 2025

Study Completion

March 1, 2026

Last Updated

August 21, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)