An interventional study of Holter Monitor and Zio Patch in Arrhythmias, Cardiac and Heart Block, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2024-06-18.
Sponsored by Columbia University · Not applicable, Interventional, and Diagnostic
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.
Patients under age 22 years at Children's Hospital of New York (CHONY) who are referred for ambulatory ECG monitoring will be consented and enrolled prospectively to have the Holter monitor and the Zio patch placed simultaneously in the pediatric cardiology clinic. Patients will be instructed to wear both devices for 48 hours. Demographic data will be collected, including date of birth, age, gender, weight, height, chest circumference, body surface area, indication for ambulatory ECG monitoring, prior congenital heart disease, prior cardiac surgery, and prior Holter or Zio patch use. A patient satisfaction survey will be given to the patient and parent/guardian after completion of the study to compare the comfort, interference with daily activities, adverse events (such as skin irritation or if either device fell off), and preference for each device. Holter monitors will be returned to the clinic along with the patient satisfaction survey, and the Zio patch will be mailed back to manufacturer headquarters and the report will be returned to the investigators.
39 studies on the registry are indexed under Heart Block; 12 are open to participants now.
This study's enrollment of 247 is above the median of 104 across 24 interventional studies indexed under Heart Block.
Browse Heart Block studies →Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
Compared within Heart Block, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Arrhythmias, Cardiac. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All subjects will wear the Holter monitor and Zio patch for a total of 48 hours.
Device: Holter Monitor · Device: Zio Patch
A Holter monitor is a battery-operated portable device that measures and records your heart's electrical activity (ECG) continuously. Patients in this study will wear the monitor for 48 hours.
The Zio Patch is a small, adhesive, water-resistant single lead electrocardiographic monitoring device. Patients in this study will wear the patch for 48 hours.
Number of Participants With Difference in Detection of Clinically Significant Arrhythmias for the Zio Versus the Holter
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).
Time frame: 48 hours
Prevalence of Artifact Detected
The aggregate percent analyzable data of the Holter monitor compared to the Zio Patch across all patients will be calculated using descriptive statistics.
Time frame: 48 hours
Percentage of Patients Who Preferred the Zio Over the Holter
Descriptive statistics will be used to analyze survey results. A one page patient satisfaction survey will be filled out at the end of the 48 hours to compare patient/parental preference and possible adverse reactions for each device.
Time frame: 48 hours
| Milestone | Holter Monitor and Zio Patch |
|---|---|
| Started | 247 |
| Completed | 200 |
| Not completed | 47 |
| Withdrew: Devices worn for <24 hrs or >72 hrs, device failing to record, or devices were lost | 47 |
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).
| participants | Holter Monitor and Zio Patch |
|---|---|
| Number of Participants With Difference in Detection of Clinically Significant Arrhythmias for the Zio Versus the Holter | 0 |
The aggregate percent analyzable data of the Holter monitor compared to the Zio Patch across all patients will be calculated using descriptive statistics.
| percentage of artifact detected | Holter Monitor | Zio Patch |
|---|---|---|
| Prevalence of Artifact Detected | 5.6 (2.4 to 15.7) | 2.8 (1.1 to 8.6) |
Descriptive statistics will be used to analyze survey results. A one page patient satisfaction survey will be filled out at the end of the 48 hours to compare patient/parental preference and possible adverse reactions for each device.
| Participants | Holter Monitor and Zio Patch |
|---|---|
| Percentage of Patients Who Preferred the Zio Over the Holter | 150 |
Collected over Up to 48 hours. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Holter Monitor and Zio Patch | 0/200 (0%) | 0/200 (0%) | 0/200 (0%) |
247 subjects were enrolled. 47 patients were excluded from the arrhythmia analysis due to one or both devices being worn for \<24 hours (n = 18) or \>72 hours (n = 4), either device failing to record (n = 11), or one or both devices being lost (n = 14). A total of 200 patients completed the study and were included for the arrhythmia analysis after attrition. The Baseline Population characteristics are reported for the final 200 participants.
| Age, Customized(Participants) | Holter Monitor and Zio Patch |
|---|---|
| 0-7 years old | 40 |
| 8-17 years old | 160 |
| 18-65 years old | 0 |
| >65 years old | 0 |
| Sex: Female, Male(Participants) | Holter Monitor and Zio Patch |
|---|---|
| Female | 87 |
| Male | 113 |
| Ethnicity (NIH/OMB)(Participants) | Holter Monitor and Zio Patch |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 0 |
| Unknown or Not Reported | 200 |
| Race (NIH/OMB)(Participants) | Holter Monitor and Zio Patch |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 200 |
| Region of Enrollment(participants) | Holter Monitor and Zio Patch |
|---|---|
| United States | 200 |
PDFs hosted by the registry, ClinicalTrials.gov.
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