Remote Interrogation of Implantable Cardiac Devices in Rural Emergency Departments
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Time to Clinical Specialist Treatment Decision
研究概览
简要总结
A retrospective, multi-center, proof-of-concept study to evaluate the use of remote monitoring in rural emergency departments to decrease time to treatment decision for pacemaker and defibrillator patients using the St Jude Medical Merlin@home transmitter. The purpose of the study is to determine if utilization of remote monitoring technology in a rural emergency department may improve patient care.
Up to 10 rural ED sites will enroll a total of 200 patients. One hundred patients will be in the remote monitoring group comprised of patients with SJM devices compatible with the unpaired transmitter and 100 patients will be in the usual medical care group comprised of patients with SJM devices that are not compatible with the unpaired transmitter or that have a competitor's device.
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
- •Presents to Emergency Department with an implanted pacemaker or defibrillator.
- •Are 18 years of age or older.
- •Are willing and able to provide informed consent for study participation.
- •Are willing and able to complete a 30-60 day follow up phone call.
排除标准
- •Are unwilling to provide written informed consent.
研究组 & 干预措施
Interrogation with Programmer
Interrogation with programmer Interrogation with programmer according to usual standard of care
Interrogation with unpaired remote monitoring transmitter
Interrogation with unpaired remote monitoring transmitter Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.
干预措施: Unpaired remote monitoring transmitter (Device)
结局指标
主要结局
Time to Clinical Specialist Treatment Decision
时间窗: 1 day
ED check in time to time of clinical specialist treatment decision.
次要结局
- Health Care Utilization Rate(Within 30 days of initial ED visit)