Remote Device Interrogation In The Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Time to Interrogation
研究概览
简要总结
A prospective, post market, non-randomized study to evaluate the reduction in time to interrogation for patients with St. Jude Medical remote care compatible devices interrogated by the unpaired Merlin@home transmitter in the Emergency Department (ED). Two sites will enroll up to 100 patients total.
Expected duration of the study is 6 months. Once enrolled the patient will participate in the study for the duration of the Emergency Department stay, until discharged or admitted to the hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Present to Emergency Department with an implanted pacemaker or defibrillator.
- •Are 18 years of age or older, or of legal age to give informed consent specific to state law.
- •Are willing and able to provide informed consent for study participation.
排除标准
- 未提供
研究组 & 干预措施
Interrogation with unpaired remote transmitter
Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.
干预措施: Unpaired remote monitoring transmitter (Device)
Interrogation with programmer
Interrogation with programmer according to usual standard of care
结局指标
主要结局
Time to Interrogation
时间窗: On day of Emergency Department admission
Time to interrogation is defined as the time from Triage (decision to interrogate the device) until the first of: Completion of interrogation, Time of Clinical/Treatment decision, or Emergency Department check out time.
次要结局
- Time to Clinical/Treatment Decision(On day of Emergency Department admission)