Comparison of Continuous Sternal ECG Patch Monitors (Carnation and Zio) Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- ECG signal quality
研究概览
简要总结
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.
详细描述
The purpose of this research is to confirm the clinical value of a new P-wave sensitive recording vector combined with an easy-to-use long-term cardiac rhythm monitoring patch system, the CarnationTM Ambulatory Monitoring (CAM) System. The P-wave is a critical aspect of the electrocardiogram and a key finding for proper arrhythmia diagnosis. The CAM system is optimized for both ease of use and for maximum P-wave clarity for arrhythmia diagnosis.
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: 14 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, using the following scale: Excellent, Good, Fair, Poor, Non-existent.
次要结局
- Device comfort(14 days)