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临床试验/NCT03309956
NCT03309956已完成不适用

Comparison of Holter With Leadless Patch Ambulatory Electrocardiographic Monitoring in Children

Columbia University1 个研究点 分布在 1 个国家目标入组 247 人开始时间: 2017年10月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
247
试验地点
1
主要终点
Number of Participants With Difference in Detection of Clinically Significant Arrhythmias for the Zio Versus the Holter

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
— 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Any patient under age 22 years who has been referred for ambulatory ECG monitoring at Children's Hospital of New York.

排除标准

  • Any known skin allergy or sensitivity to adhesive material.

结局指标

主要结局

Number of Participants With Difference in Detection of Clinically Significant Arrhythmias for the Zio Versus the Holter

时间窗: 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).

次要结局

  • Prevalence of Artifact Detected(48 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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