N/A
Completed N=247
Holter Versus Zio Patch Electrocardiographic Monitoring in Children
Arrhythmias, Cardiac · Heart Failure
Source: ClinicalTrials.gov NCT03309956 ↗
Enrolled (actual)
247
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcomePrimary: Number of Participants With Difference in Detection of Clinically Significant Arrhythmias for the Zio Versus the Holter — 0 participants — p=0.23
Summary
This prospective study aims to compare the diagnostic yield, or ability to detect an arrhythmia, of the traditional Holter monitor versus the novel Zio patch monitor in pediatric patients referred for ambulatory electrocardiographic (ECG) monitoring. Children will wear both devices simultaneously for 48 hours and the incidence of clinically significant arrhythmias will be compared.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Difference in Detection of Clinically Significant Arrhythmias for the Zio Versus the Holter |
— | 0.23 |
| SECONDARY Prevalence of Artifact Detected |
5.6; 2.8 | — |
Eligibility Criteria
Inclusion Criteria
- Any patient under age 22 years who has been referred for ambulatory ECG monitoring at Children's Hospital of New York.
Exclusion Criteria
- Any known skin allergy or sensitivity to adhesive material.
Data sourced from ClinicalTrials.gov (NCT03309956). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.