NCT02253134已完成不适用
Monitoring of Syncopes and/or Sustained Palpitations of Suspected Arrhythmic Origin With External Loop-Recorder (SpiderFLASH)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- LivaNova
- 入组人数
- 395
- 试验地点
- 10
- 主要终点
- Evaluate the mean value of the diagnostic yield in one month
研究概览
简要总结
The purpose of this study is to evaluate the diagnostic yield (at 1 month post enrollment) of an external loop recorder (SpiderFlash-T) in patients with syncope or palpitations of suspected arrhythmic origin, within 30 days before enrollment.
详细描述
Diagnostic yield (primary outcome) definition = Number of patients with conclusive diagnosis (as per investigators' decision) over the total number of patients
研究设计
- 研究类型
- Observational
- 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 and/or palpitations events occurred in the last 30 days
- •Events likely of arrhythmic origin
- •No conclusive diagnosis established yet
- •High probability of episodes recurrence (presence of at least one previous event in the last 12 months)
- •Patient has signed the consent to participate to the study and/or to data treatment
排除标准
- •Inability to understand the purpose of the study or refusal to cooperate
- •Expected low compliance with the recording technique.
- •Logistical impossibility to deliver the ELR within 30 days after the index event (or after discharge from ER and/or hospitalization and/or clinic visit)
- •Already included in other competitor clinical study
- •Under guardianship
- •Age less than 18
结局指标
主要结局
Evaluate the mean value of the diagnostic yield in one month
时间窗: 1 month
number of pts with a conclusive diagnosis (per investigators' decision) over the total number of patients
次要结局
- Recurrence rate stratified by syncope /palpitation, by week and by type of events occurred post enrollment(1 month)
- Analysis of arrhythmic vs non arrhythmic findings stratified by kind of index events (syncope /palpitations)(1 month)
- Diagnostic yield of the ELR stratified by each kind of diagnosed event, by week and by event occurred post enrollment(1 month)
研究者
研究点 (10)
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