HeartStart FRx Defibrillator Event Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- Unexpected adverse events.
研究概览
简要总结
This post market clinical follow-up study is a multi-center, non-randomized, unblinded, observational registry of the performance of the FRx Automated external defibrillator (AED) used in conjunction with electrodes with or without use of the infant/child key. The registry is focused only on on post-event data collection and does not prescribe any device usage. This registry has several safeguards in place to prevent against selections bias, including enrollment of all participants who have pads placed. This registry will evaluate the safety and verify the clinical performance of the device in relation to its claims, when used in accordance with the Device Manual.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects accepted into the study must: have been suspected of a circulatory arrest for any cause
- •Have had HeartStart FRx AED with electrodes: HeartStart SMART PADS II applied to their body and powered up, regardless of whether a defibrillation shock was delivered
排除标准
- •AED or pad use other than the HeartStart FRx AED with electrodes : HeartStart SMART PADS II
- •AED used for training purposes.
研究组 & 干预措施
Suspected Sudden Cardiac Arrest
All subject with suspected of a circulatory arrest for any cause.
干预措施: HeartStart FRX (Device)
结局指标
主要结局
Unexpected adverse events.
时间窗: 1 day
Frequency and severity of unexpected adverse events.
Unanticipated adverse device effects (UADE)
时间窗: 1 day
Unanticipated adverse device effects (UADE)
Algorithm accuracy
时间窗: Up to 15 minutes after device placement
Algorithm performance as determined by adjudication of the wave form data as aligned with the device advisement.
Shock Delivery
时间窗: 1 day
Percentage of events where a shock was delivered when indicated.
次要结局
- Time Intervals(1 day)
- Pad Replacement(1 day)
- User(1 day)
- Device Preparation(1 day)
- Shock Energy Delivered(1 day)