Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Holter Monitor and Zio Patch | Other | All subjects will wear the Holter monitor and Zio patch for a total of 48 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Holter Monitor | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 hours |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Leonardo Liberman, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24384108 | Background | Barrett PM, Komatireddy R, Haaser S, Topol S, Sheard J, Encinas J, Fought AJ, Topol EJ. Comparison of 24-hour Holter monitoring with 14-day novel adhesive patch electrocardiographic monitoring. Am J Med. 2014 Jan;127(1):95.e11-7. doi: 10.1016/j.amjmed.2013.10.003. Epub 2013 Oct 15. | |
| 25591894 | Background | Bolourchi M, Batra AS. Diagnostic yield of patch ambulatory electrocardiogram monitoring in children (from a national registry). Am J Cardiol. 2015 Mar 1;115(5):630-4. doi: 10.1016/j.amjcard.2014.12.014. Epub 2014 Dec 18. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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. | Posted | Number | participants | 48 hours |
|
Up to 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. Adverse Events were monitored and reported for the final 200 participants.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leonardo Liberman, MD | Columbia University | 212-305-8509 | ll202@cumc.columbia.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 26, 2018 | Sep 20, 2021 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006327 | Heart Block |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D015716 | Electrocardiography, Ambulatory |
| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
Not provided
Not provided
All patients will receive the same intervention, namely both devices at the same time for 48 hours.
Not provided
Not provided
Not provided
Not provided
| Zio Patch | Device | 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. |
|
| 24976467 | Background | Cheung CC, Kerr CR, Krahn AD. Comparing 14-day adhesive patch with 24-h Holter monitoring. Future Cardiol. 2014 May;10(3):319-22. doi: 10.2217/fca.14.24. |
| 24215754 | Background | Lobodzinski SS. ECG patch monitors for assessment of cardiac rhythm abnormalities. Prog Cardiovasc Dis. 2013 Sep-Oct;56(2):224-9. doi: 10.1016/j.pcad.2013.08.006. |
| 23240827 | Background | Rosenberg MA, Samuel M, Thosani A, Zimetbaum PJ. Use of a noninvasive continuous monitoring device in the management of atrial fibrillation: a pilot study. Pacing Clin Electrophysiol. 2013 Mar;36(3):328-33. doi: 10.1111/pace.12053. Epub 2012 Dec 13. |
| 24672611 | Background | Schreiber D, Sattar A, Drigalla D, Higgins S. Ambulatory cardiac monitoring for discharged emergency department patients with possible cardiac arrhythmias. West J Emerg Med. 2014 Mar;15(2):194-8. doi: 10.5811/westjem.2013.11.18973. |
| 25628595 | Background | Tung CE, Su D, Turakhia MP, Lansberg MG. Diagnostic Yield of Extended Cardiac Patch Monitoring in Patients with Stroke or TIA. Front Neurol. 2015 Jan 12;5:266. doi: 10.3389/fneur.2014.00266. eCollection 2014. |
| 23672988 | Background | Turakhia MP, Hoang DD, Zimetbaum P, Miller JD, Froelicher VF, Kumar UN, Xu X, Yang F, Heidenreich PA. Diagnostic utility of a novel leadless arrhythmia monitoring device. Am J Cardiol. 2013 Aug 15;112(4):520-4. doi: 10.1016/j.amjcard.2013.04.017. Epub 2013 May 11. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 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. | 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. | Posted | Median | Inter-Quartile Range | percentage of artifact detected | 48 hours |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | 48 hours |
|
|
|
| 0 |
| 200 |
| 0 |
| 200 |
| 0 |
| 200 |
Not provided
Not provided
Not provided
| D000075224 | Cardiac Conduction System Disease |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
| D018670 | Monitoring, Ambulatory |
| D008991 | Monitoring, Physiologic |