Comparison of Continuous Sternal ECG Patch Monitors (Carnation and Zio) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- ECG signal quality
研究概览
简要总结
The purpose of this research is to test the clinical value of a new P-wave sensitive recording vector compared to a standard ECG limb lead II vector from similar easy-to-use long-term cardiac rhythm monitoring patch systems, the Carnation TM Ambulatory Monitoring (CAM) System and the Zio-XT iRhythm. The P-wave is a critical aspect of the electrocardiogram. The purpose of this study is to see if the P-wave centric focus of the CAM system improves arrhythmia diagnosis.
详细描述
This study is intended to compare the new Carnation patch monitoring system with the Zio patch, which represents the current standard for continuous recording of the ECG over extended periods. The primary endpoint for this comparison will be diagnostic yield with secondary endpoints being ease of use and comfort.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •Male or female
- •Written informed consent
- •Patients with one or more of the following:
- •Syncope of uncertain etiology; or
- •Pre-syncope of uncertain etiology; or
- •Palpitations of uncertain etiology; or
- •Management of known AF/SVT patients
排除标准
- •Any dermatitis or infected skin over the sternum (Carnation patch) or left upper anterior thorax (Zio patch).
- •A sternal or thoracic incision that extends under the patch within 3 months from the date of enrollment.
- •Cognitive deficits that would interfere with the subject's ability to give informed consent or perform study testing
结局指标
主要结局
ECG signal quality
时间窗: 7 days
ECG signal quality = scoring the ability of each system to record electrical activity from the atrium (P-waves). The Physician Event Committee will independently score the P-waves from all recordings.
次要结局
- Skin comfort or discomfort: Was skin irritated?(7 days)
- Device Comfort(7 days)
- Device Stability and Contact(7 days)
- Diagnostic Yield(7 days)