Remote Implant Support
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Successful Support
研究概览
简要总结
The purpose of this study is to gain real world, live implant experience with the remote implant support system. This system is intended to provide the technical support for device implants from a remote location through telepresence (audio and video) and remote control. Specifically, the goals of this study are to corroborate bench testing, assess the performance of the system, gain understanding of the workflows, customer experience, and logistics.
The intent of the remote support model is to provide the same support that would typically be provided by a local support person, only remotely. As such, the remote support person would only perform actions that a local support person would routinely do under the direction of a physician. This may involve observing patient data, providing technical support and advice, and performing testing and device reprogramming via remote control of the programmer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Planned IPG implant or planned ICD (without CRT) implant
- •Signed informed consent
排除标准
- •Pacing dependency
- •Defibrillation threshold testing planned
- •Basal ventricular rate >110 beats per minute
- •Younger than 18 years
- •Currently involved in another IPG or ICD related clinical trial
结局指标
主要结局
Successful Support
时间窗: At implant
Percentage of implant attempts with successful support. If the local support person does not participate in any part of the surgery, other than observing, then the remote support will be called a success.
System Integrity
时间窗: At implant
Percentage of patients whose implantable devices with clinically equivalent programming by remote support and local support.
次要结局
未报告次要终点