HeartStart HS1 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
- Defibrillation success
研究概览
简要总结
A Prospective study on the performance and safety of the HeartStart OnSite (Model M5066A) & HeartStart Home (Model M5068A) Defibrillator device data.
详细描述
The objective of this PMCF (Post Market Clinical Follow-up) prospective collection of post-event data registry is to confirm the safety and performance as expressed in the energy delivery by the HeartStart HS1 Defibrillator (HeartStart OnSite and Home models in North America) in the population for the device's intended use in reference to its commercial labeling, and in relationship to the type of pads attached to the device.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have been suspected of a circulatory arrest for any cause.
- •Have had HeartStart HS1 Defibrillator with electrodes:
- •Adult SMART Pads Cartridge [REF: M5071A], Infant/Child SMART Pads Cartridge (REF:M5072A) applied to their body and powered up with HS1 battery (Model M5070A), regardless of whether a defibrillation shock was delivered
排除标准
- •Subjects will be excluded if any of the following are present:
- •AED or pad use other than the HeartStart HS1 Defibrillator with above referenced Philips electrode pads. Note: Use of a device other than the Philips HeartStart HS1 AED does not preclude enrollment if the AED or an Advanced Life Support defibrillator was used after the HeartStart HS1 AED.
- •AED used for training purposes.
研究组 & 干预措施
Suspected Sudden Cardiac Arrest
All subjects with suspected of a circulatory arrest of any cause.
干预措施: HeartStart HS1 (Device)
结局指标
主要结局
Defibrillation success
时间窗: Up to 15 minutes during device placement
Defibrillation success and the number of shocks required for success.
Mean shock energy delivered in the adult population
时间窗: Up to 15 minutes during device placement
Mean of shock energy delivered, when the adult defibrillation pads were attached to the AED as intended for in children and adults over 25 kilograms / 55 pounds or greater than 8 years old.
The Patient Analysis System (PAS) shock advisory algorithm performance as determined by evaluation of the ECG as aligned with the device advisement.
时间窗: Up to 15 minutes during device placement
Performance is defined by the sensitivity and specificity; positive predictive value and false positive rate will be reported for each rhythm category (as defined by device labeling).
Mean shock energy delivered in the pediatric population
时间窗: Up to 15 minutes during device placement
Mean of shock energy delivered, when the pediatric defibrillation pads were attached to the AED as intended for infants and children under 25 kilograms / 55 pounds or 0-8 years old.
Accurate detection of shockable rhythms and facilitation of shocks.
时间窗: Up to 15 minutes during device placement
The percentage of events where a shockable rhythm was identified by the device, the device advised a shock, and the device delivered a shock when the shock button was pressed.
次要结局
- CPR activity(Up to 15 minutes during device placement)
- Unanticipated adverse device effects (UADE)(Up to 15 minutes during device placement)
- Energy delivered consistent with device labeling(Up to 15 minutes during device placement)
- CPR guidance initiated (i-button pushed)(Up to 15 minutes during device placement)
- Aborted shocks because of low or high impedance(Up to 15 minutes during device placement)
- Median operating time intervals(Up to 15 minutes during device placement)
- Frequency and severity of unexpected adverse events(Up to 15 minutes during device placement)
- Pad replacement notification(Up to 15 minutes during device placement)
- Shock button effectively pressed after shock advisement(Up to 15 minutes during device placement)
- Indicators of battery status/depletion (device logged data)(Up to 15 minutes during device placement)
- Routine self-test performance/Battery Insertion self-test performance(Up to 15 minutes during device placement)
- Device arming after shock advisement.(Up to 15 minutes during device placement)