NCT01725568已完成不适用
Master Study of the Implantable Cardiac Monitor "BioMonitor"
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- SADE free-rate
研究概览
简要总结
The BioMonitor is an implantable cardiac monitor used to automatically detect and record episodes of arrhythmia in patients with bradycardia, tachycardia, asystole and atrial fibrillation. The study will be conducted to support regulatory approvals outside of Europe. This BioMonitor Master study is designed to investigate the clinical efficacy and safety of the BioMonitor.
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
- •Suspected cardiac arrhythmia OR Previous AF diagnosis OR AF diagnosis before or after ablation procedure OR Stroke of unknown origin.
排除标准
- •Implanted ICD or cardiac pacemaker
- •Allergy to patch electrodes
结局指标
主要结局
SADE free-rate
时间窗: at 3 month follow-up
SADE free-rate \> 90% at 3 month follow-up
Rate of appropriate QRS detection
时间窗: at 6 week follow-up
Rate of appropriate QRS detection \> 90% (based on comparison with Holter ECG recording)
次要结局
未报告次要终点
研究者
研究点 (1)
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