Identification of Implantable Cardioverter Defibrillator Patients With Remote Follow up That Requires an Onsite Visit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 354
- 试验地点
- 1
- 主要终点
- Remote Follow-up as an Alternative to Onsite Visit
研究概览
简要总结
With the expansion of Sudden Cardiac Death (SCD) primary prevention indications, the number of Implantable Cardioverter Defibrillators (ICD) implants has increased significantly in the recent years. This has resulted in an increase of the number of follow-up (FU) to be performed and a growing workload for centers. Remote FU system such as the Medtronic Carelink system allows to check remotely the proper functioning of self evaluating devices and give informations of some clinical events.
The objective of this study is to define which patients with a remote follow-up need additional onsite visit and to assess to which extent remote FU can be an alternative to onsite visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient older than 18,
- •Patient implanted with a fully automatic ICD and remotely followed-up,
- •Patient geographically stable and able to attend FU at investigative site
- •Patient who signed a data release authorization form,
排除标准
- •Patient whose mental or physical capacity impedes to give an informed data release authorization,
- •Patient already enrolled in a clinical study whose procedures may interfere with the results of the present study,
- •Patients in New York Heart Association (NYHA) class IV
结局指标
主要结局
Remote Follow-up as an Alternative to Onsite Visit
时间窗: 13 months
Evaluate the percentage of patients who had a successful remote follow up, as an alternative to onsite visit for patients implanted with a fully automatic ICD
次要结局
未报告次要终点