Comparison of Short Term Holter Monitoring vs. Long Term Zio(R)Patch True Continuous ECG Monitoring (TCEM Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Arrhythmia detection for Zio® patch and the traditional ambulatory Holter monitor.
研究概览
简要总结
The purpose of this study is to compare short term (up to 48 hours) traditional cardiac rhythm monitoring using a standard ambulatory Holter monitor versus long term (up to 14 days), continuous ambulatory cardiac rhythm monitoring using a new device cleared by the FDA (Zio® Patch), iRhythm Technologies, Inc., San Francisco CA) in patients with suspected cardiac arrhythmias.
详细描述
This is a prospective, observational study of patients seen in the Holter lab at Scripps Green Hospital and other Scripps Clinic locations. Only patients who have indications for traditional cardiac rhythm monitoring will be enrolled in the study. Patients 18 years or older with suspected arrhythmias capable of providing informed consent will wear both a traditional Holter monitor for up to 48 hours and a Zio® Patch for up to 14 days. Both devices will be initiated at the same time as they do not interfere with one another. This will also allow a direct comparison of the same initial up to 24 hour monitoring period between the two devices. As the Zio® Patch is worn for up to 14 days instead of only 24 hours, it will be assessed if in the physician's opinion (referring physician), waiting for the extended time hinders being able to provide medical care and/or diagnosis for the patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are being seen in the outpatient office for evaluation, treatment, or follow-up of arrhythmias;
- •Have a medical history for which ascertaining whether asymptomatic arrhythmias is occurring could be helpful in their treatment plan;
- •Are capable of giving informed consent; assessed by the investigator or the Study Coordinator;
- •Are 18 years of age or older;
- •Able to comply with long term continuous monitoring ECG device.
排除标准
- •Have known skin allergies, conditions, or sensitivities (e.g. allergy to adhesives, psoriasis) as the Zio(R)Patch should not be used on patients with known skin allergies, conditions, or sensitivities; or
- •Are receiving pacing therapy (e.g., from a pacemaker); or
- •Are anticipated to receive or require external cardiac defibrillation during the monitoring period; or
- •Are anticipated to be exposed to high frequency surgical equipment during the monitoring period.
结局指标
主要结局
Arrhythmia detection for Zio® patch and the traditional ambulatory Holter monitor.
时间窗: Up to 14 days.
Data will be examined to determine the difference in the number of 6 types of arrhythmias detected at maximum observation times of 14 days and 24 hours respectively. In comparing the difference of the number of arrhythmias for the Zio® Patch and the Holter data, we are expecting a skewed distribution of the differences and will use a paired Wilcoxon Signed Rank Test since the normality assumption is not met for a paired t-test. If the difference is significantly greater than zero, there is evidence that the Zio® Patch is an improvement in this sample.
次要结局
- Subjects ease in comfort for the Zio® Patch and the traditional ambulatory Holter monitor.(Up to14 days.)