Multicenter Evaluation of Patients Using LATITUDE Monitoring System: Multitude Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20,000
- 试验地点
- 3
- 主要终点
- Mortality
研究概览
简要总结
The Multitude is a registry of patients who receive commercially available CIEDs that remotely communicate through the LATITUDE monitoring system and transfer data to a central database.
The registry is designed to constitute a shared environment for the collection, management, analysis and reporting of clinical and diagnostic data, adopted by a network of European scientifically-motivated physicians who use rhythm management diagnostic and therapeutic solutions from Boston Scientific in their clinical practice.
The Multitude study will facilitate the sharing of scientific proposals within a large network of researchers, and it will allow researchers to record the experience with medical devices throughout the device and patient lifecycle.
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
- •Subject is willing and capable of providing informed consent to collect/store/process personal health information by the sponsor or such consent is provided by a legally designated representative, if required by local law or regulation.
- •Subject is:
- •prospectively scheduled for receiving a device monitored through the LATITUDE monitoring system
- •retrospectively enrolled after having received a device monitored through the LATITUDE monitoring system
排除标准
- •Subject foreseen not to be followed at the enrolling center for at least 1 year after having received the device.
- •Subject is receiving a device that is not approved for commercial use at the time of procedure.
结局指标
主要结局
Mortality
时间窗: 10 years
Mortality
次要结局
- Device therapy(10 years)
- Device-related complications(10 years)
- Hospitalization(10 years)