NCT03009175已完成不适用
Patient Risk Triage in ICD Remote Follow-up Observational Study (PRoMOTE FU)
Medtronic Cardiac Rhythm and Heart Failure0 个研究点目标入组 287 人开始时间: 2013年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 287
- 主要终点
- Clinical Data collected through the phone call to the patients during the 6 months of study duration will be correlated to the HF risk classification provided by the HFRS feature on each transmission.
研究概览
简要总结
The purpose of the study is:
- To evaluate the Heart Failure Risk Status (HFRS) feature performance.
- To establish the feasibility of remote follow-up in which patient risk triaging is performed by nurse-led review of HFRS feature as supplemental information.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients that meet all of following criteria could be included in the study:
- •Implant of a commercially available Medtronic CRTD or ICD device with or without the Optivol Fluid Status Monitoring feature.
- •Inclusion in the Medtronic Carelink Network.
- •Local consent available for CL network as well as general local consent available for the use of data in observational studies signed and informative sheet delivered.
排除标准
- •Patients under the age of 18 years.
结局指标
主要结局
Clinical Data collected through the phone call to the patients during the 6 months of study duration will be correlated to the HF risk classification provided by the HFRS feature on each transmission.
时间窗: 6 months
次要结局
未报告次要终点
研究者
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