NCT01173783已完成不适用
Deutsches Device Qualitätsregister
Stiftung Institut fuer Herzinfarktforschung7 个研究点 分布在 1 个国家目标入组 4,008 人开始时间: 2007年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4,008
- 试验地点
- 7
- 主要终点
- Characterize consecutive patients with initial implantation of ICD or CRT in hospital daily routine in Germany
研究概览
简要总结
It is the aim of this register to document the development of therapies by implantation of Cardioverter/Defibrillators (ICDs) and/or Cardiac Resynchronization therapy (CRT)-Systems.
详细描述
The possibility of evaluation of successes as well as of the complications of these therapies is needed to make quality management possible. Every German Center, implanting ICDs or CRT-devices, is encouraged to contribute to this register; data are collected by use of an electronical CRF.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The Device register will include all consecutive patients with an intended implantation of an ICD / CRT.
排除标准
- •Missing signed informed consent
结局指标
主要结局
Characterize consecutive patients with initial implantation of ICD or CRT in hospital daily routine in Germany
时间窗: 01/03/2007-12/31/2011
次要结局
- Specification of the device and the realization of the implantation as well as the success of the operation(01/03/2007-12/31/2011)
- Documentation of further interventions needed after the Index Event during hospital stay(01/03/2007-12/31/2011)
- Documentation of medication therapy after 12 months(01/03/2007-12/31/2011)
- Documentation of hospital mortality and non-fatal complications(01/03/2007-12/31/2011)
- Documentation of the dispensary of shocks within one year(01/03/2007-12/31/2011)
- Documentation of the 1-year mortality and non-fatal complications(01/03/2007-12/31/2011)
- Documentation of symptomatology and number of hospitalizations(01/03/2007-12/31/2011)
研究者
研究点 (7)
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