NCT04206774已完成不适用
BIO|STREAM.ICM France, Submodule of the BIO|STREAM.ICM Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 3
- 主要终点
- SADE free rate
研究概览
简要总结
The main objective of the BIO│STREAM.ICM France submodule is to provide clinical evidence from patients in France on safety and efficacy of the BIOMONITOR system
详细描述
The BIO|STREAM.ICM submodule will recruit a subset of patients with syncope with uncertain origin and cryptogenic stroke without history of atrial arrhythmia from the existing population enrolled in the BIO|STREAM.ICM registry. The submodule study is designed to provide clinical evidence from patients in France on safety and efficacy of the BIOMONITOR System.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Indication for ICM device in accordance with the European guidelines: syncope with uncertain origin or cryptogenic stroke without history of atrial arrhythmia
- •Enrolled in the BIO|STREAM.ICM registry
排除标准
- •Life-expectancy is less than 3 months
- •Already implanted with BIOMONITOR
结局指标
主要结局
SADE free rate
时间窗: 3 month
Serious adverse device effect (SADE) free rate related to the BIOMONITOR system
次要结局
未报告次要终点
研究者
研究点 (3)
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