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临床试验/NCT01230073
NCT01230073已完成4 期

Treatment Satisfaction With Remote Monitoring in Implantable Cardioverter Defibrillator Recipients

Deutsches Herzzentrum Muenchen2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2011年2月1日最近更新:
适应症
干预措施

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

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

Active Comparator

Home-Monitoring

干预措施: Home-Monitoring (Device)

Home-Monitoring

Active Comparator

Home-Monitoring

干预措施: Follow-up by Home-Monitoring (Device)

ICD traditional follow-up

Active Comparator

ICD with traditional follow-up in the outpatient clinic

干预措施: Home-Monitoring (Device)

ICD traditional follow-up

Active Comparator

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)

研究者

发起方
Deutsches Herzzentrum Muenchen
申办方类型
Other
责任方
Sponsor

研究点 (2)

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