Apple Watch for Pediatric Arrhythmia

(PAWS Trial)

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Age < 6, Developmental ability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on monitoring heart rhythms with the Apple Watch, so you may not need to change your medication routine.

What data supports the effectiveness of the Apple Watch as a treatment for pediatric arrhythmia?

Research shows that the Apple Watch can accurately measure heart rhythms in children, similar to traditional ECGs, which helps in identifying arrhythmias (irregular heartbeats). This means it can be a useful tool for monitoring heart conditions in kids without needing frequent hospital visits. ^{1 2 3 4 5}

Is the Apple Watch safe for use in children for monitoring heart conditions?

The Apple Watch has been studied for its ability to monitor heart rhythms in children, and while it shows promise in detecting arrhythmias, specific safety data for children is limited. However, the device is generally considered safe for use in adults, and studies in children have not reported significant safety concerns. ^{1 2 3 6 7}

How does the Apple Watch treatment for pediatric arrhythmia differ from other treatments?

The Apple Watch offers a unique approach to monitoring pediatric arrhythmias by using its iECG function to capture heart rhythms in real-time, allowing for remote monitoring without the need for hospital visits. This is different from traditional methods like the Holter monitor, which requires wearing a device for a set period and often involves more frequent hospital visits. ^{1 2 3 5 6}

Research Team

Scott Ceresnak, MD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for children and young adults aged 6 to 21 who are undergoing monitoring for heart rhythm problems. Participants must be able to wear an Apple Watch safely and use its features, including the trigger buttons.

Inclusion Criteria

I can safely use an Apple Watch and its buttons.

I am between 6 and 21 years old and need heart rhythm monitoring.

Exclusion Criteria

I cannot use an Apple Watch.

I am under 6 years old.

You are unable to use the monitor or watch's special features effectively.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will wear an Apple Watch to monitor heart rate and detect arrhythmias

6 months

Initial setup visit (in-person), periodic virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Apple Watch

Trial Overview The study aims to test how accurately the Apple Watch can record ECG tracings and heart rate in kids. It also looks at whether using the watch longer term catches any arrhythmias that shorter clinical tests might miss.

Participant Groups

Group I: Apple Watch Experimental Treatment 1 Intervention

Participants will wear an Apple Watch for 6 months

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Assessment of Apple Watch Series 6 pulse oximetry and electrocardiograms in a pediatric population. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Utility of smart watches for identifying arrhythmias in children. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Accuracy of the Apple Watch iECG in Children With and Without Congenital Heart Disease. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Pediatric arrhythmias: which are the news? [2009]

5. United States pubmed.ncbi.nlm.nih.gov

Comparison of Holter With Zio Patch Electrocardiography Monitoring in Children. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Recording an ECG With a Smartwatch in Newborns and Young Children: Feasibility and Perspectives. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Comparison of 2 Smart Watch Algorithms for Detection of Atrial Fibrillation and the Benefit of Clinician Interpretation: SMART WARS Study. [2022]