Comparison of a Sternal ECG Patch With a Standard Recording System for Holter Monitoring
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- ECG signal quality
研究概览
简要总结
This study is intended to compare the new Carnation Ambulatory Monitoring (CAM) System, a patch monitoring system, with the Holter monitoring system. Holters represent the current standard for continuous recording of the ECG over extended periods.
详细描述
The purpose of this research is to simplify the system of recording ECGs. Carnation Ambulatory Monitoring (CAM) System is a small patch system that can be worn during most activities include showering. Each patient will be his or her own control, and will wear the CAM and Holter systems simultaneously for 24 hours. Both systems will then be sent out for analysis.
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
- •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
结局指标
主要结局
ECG signal quality
时间窗: 24 hours of patient use, plus shipping and analysis time ~ 2 weeks
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, using the following scale: Excellent, Good, Fair, Poor, Non-existent. Diagnostic yield will also be assessed.
次要结局
- Device comfort(24 hours)