Arrhythmias, Cardiac, Heart Block
Conditions
Keywords
Ambulatory Electrocardiography, Holter Monitor, Zio Patch Monitor, Pediatrics
Brief 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.
Detailed description
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.
Interventions
DEVICEHolter Monitor
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.
DEVICEZio Patch
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.
Sponsors
Columbia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
All patients will receive the same intervention, namely both devices at the same time for 48 hours.
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Difference in Detection of Clinically Significant Arrhythmias for the Zio Versus the Holter | 48 hours | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Artifact Detected | 48 hours | The aggregate percent analyzable data of the Holter monitor compared to the Zio Patch across all patients will be calculated using descriptive statistics. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Who Preferred the Zio Over the Holter | 48 hours | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Holter Monitor and Zio Patch All subjects will wear the Holter monitor and Zio patch for a total of 48 hours.
Holter Monitor: 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.
Zio Patch: 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.
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. | 200 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Devices worn for <24 hrs or >72 hrs, device failing to record, or devices were lost | 47 |
Baseline characteristics
| Characteristic | Holter Monitor and Zio Patch |
|---|---|
| Age, Customized 0-7 years old | 40 Participants |
| Age, Customized 18-65 years old | 0 Participants |
| Age, Customized >65 years old | 0 Participants |
| Age, Customized 8-17 years old | 160 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 200 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 200 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 200 participants |
| Sex: Female, Male Female | 87 Participants |
| Sex: Female, Male Male | 113 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 200 |
| other Total, other adverse events | 0 / 200 |
| serious Total, serious adverse events | 0 / 200 |
Outcome results
Primary
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
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Holter Monitor and Zio Patch | Number of Participants With Difference in Detection of Clinically Significant Arrhythmias for the Zio Versus the Holter | 0 participants |
p-value: 0.23McNemar
Secondary
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
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Holter Monitor and Zio Patch | Prevalence of Artifact Detected | 5.6 percentage of artifact detected |
| Zio Patch | Prevalence of Artifact Detected | 2.8 percentage of artifact detected |
Other Pre-specified
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
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Holter Monitor and Zio Patch | Percentage of Patients Who Preferred the Zio Over the Holter | 150 Participants |