Treatment Satisfaction With Remote Monitoring in Implantable Cardioverter Defibrillator Recipients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Treatment satisfaction with ICD therapy and follow-up
研究概览
简要总结
Remote monitoring of implantable cardioverter defibrillators (ICD) is a promising new development in ICD therapy and has been shown to be technically feasible and safe.While data on safety and feasibility of remote monitoring are in favour of this technology, patients´ treatment satisfaction has not been sufficiently investigated. To date, there is only one small, non-randomised study investigating patients´ treatment satisfaction in highly selected and highly motivated patients at the time of implantation and 12 months thereafter7. Therefore, the aim of the San Remo Trial is to investigate factors that are associated with patients´ willingness to accept the new method of follow-up on a broad basis of ICD recipients and to determine their treatment satisfaction with ICD therapy in a randomised, prospective trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICD indication according to current national or international guidelines
- •Patient available for follow-up during study period
排除标准
- •Clinically unstable medical conditions that require regular outpatient clinic follow-up
研究组 & 干预措施
Home-Monitoring
Home-Monitoring
干预措施: Home-Monitoring (Device)
Home-Monitoring
Home-Monitoring
干预措施: Follow-up by Home-Monitoring (Device)
ICD traditional follow-up
ICD with traditional follow-up in the outpatient clinic
干预措施: Home-Monitoring (Device)
ICD traditional follow-up
ICD with traditional follow-up in the outpatient clinic
干预措施: Follow-up by Home-Monitoring (Device)
结局指标
主要结局
Treatment satisfaction with ICD therapy and follow-up
时间窗: 12 months
次要结局
- Number of healthcare consultations(12 months)
