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Trial Outcomes & Findings for Holter Versus Zio Patch Electrocardiographic Monitoring in Children (NCT NCT03309956)

NCT ID: NCT03309956

Last Updated: 2024-06-18

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

247 participants

Primary outcome timeframe

48 hours

Results posted on

2024-06-18

Participant Flow

Participant milestones

Participant milestones
Measure
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.
Overall Study
STARTED
247
Overall Study
COMPLETED
200
Overall Study
NOT COMPLETED
47

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
Overall Study
Devices worn for <24 hrs or >72 hrs, device failing to record, or devices were lost
47

Baseline Characteristics

Holter Versus Zio Patch Electrocardiographic Monitoring in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Holter Monitor and Zio Patch
n=200 Participants
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.
Age, Customized
0-7 years old
40 Participants
n=5 Participants
Age, Customized
8-17 years old
160 Participants
n=5 Participants
Age, Customized
18-65 years old
0 Participants
n=5 Participants
Age, Customized
>65 years old
0 Participants
n=5 Participants
Sex: Female, Male
Female
87 Participants
n=5 Participants
Sex: Female, Male
Male
113 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
200 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
0 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
200 Participants
n=5 Participants
Region of Enrollment
United States
200 participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure
Holter Monitor and Zio Patch
n=200 Participants
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.
Zio Patch
All subjects will wear the Holter monitor and Zio patch for a total of 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.
Number of Participants With Difference in Detection of Clinically Significant Arrhythmias for the Zio Versus the Holter
0 participants
—

SECONDARY outcome

Timeframe: 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.

The aggregate percent analyzable data of the Holter monitor compared to the Zio Patch across all patients will be calculated using descriptive statistics.

Outcome measures

Outcome measures
Measure
Holter Monitor and Zio Patch
n=200 Participants
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.
Zio Patch
n=200 Participants
All subjects will wear the Holter monitor and Zio patch for a total of 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.
Prevalence of Artifact Detected
5.6 percentage of artifact detected
Interval 2.4 to 15.7
2.8 percentage of artifact detected
Interval 1.1 to 8.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Holter Monitor and Zio Patch
n=200 Participants
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.
Zio Patch
All subjects will wear the Holter monitor and Zio patch for a total of 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.
Percentage of Patients Who Preferred the Zio Over the Holter
150 Participants
—

Adverse Events

Holter Monitor and Zio Patch

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Leonardo Liberman, MD

Columbia University

Phone: 212-305-8509

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place