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NCT03309956 · ClinicalTrials.gov registry record · NA
Holter Versus Zio Patch Electrocardiographic Monitoring in Children
A NA study, sponsored by Columbia University.
- Completed
- Registry status
- NA
- Development phase
- 247
- Enrollment target
NCT03309956: Completed NA study, sponsored by Columbia University.
NCT03309956 is a NA study that has completed, run by Columbia University. The registered enrollment target is 247 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03309956, a NA study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- NA
- Development phase
- 247 participants
- Enrollment target
Study 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.
Primary Outcome
The diagnostic yield, or the ability to detect an arrhythmia, will be measured for the Holter monitor and the Zio patch monitor for each patient. The diagnostic yield for each arrhythmia subtype will be determined for each device across all patients and compared in paired statistical analysis (McNemar's test).
Interventions
- DEVICE Zio Patch
- DEVICE Holter Monitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 247 participants |
| Start Date | 2017-10-18 |
| Est. Completion | 2019-10-19 |
| Phase | NA |
What the finished NCT03309956 record still lists
NCT03309956 is an interventional study that assigns participants to a tested intervention. The registered 247 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Zio Patch is the first listed.
NCT03309956 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03309956 about?
NCT03309956 is a clinical study titled "Holter Versus Zio Patch Electrocardiographic Monitoring in Children". 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 fo...
What is the current status of trial NCT03309956?
This trial is currently completed. It is a NA study. The enrollment target is 247 participants. The study started on 2017-10-18. Estimated completion is 2019-10-19.
What interventions are being tested in trial NCT03309956?
The interventions under investigation include: Zio Patch (DEVICE), Holter Monitor (DEVICE).
Who is sponsoring clinical trial NCT03309956?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03309956's enrollment target sits among peer trials
247 436th of 2000 higher than 1,565 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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