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2007年3月

适应症Heart Failure

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Heart Failure
发起方: Stiftung Institut fuer Herzinfarktforschung
入组人数: 4008
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
状态: 已完成
最后更新: 9年前

概览研究者入排标准结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2007年3月

结束日期

2011年8月

最后更新

9年前

研究类型

Observational

性别

All

研究者

发起方

Stiftung Institut fuer Herzinfarktforschung

责任方

Sponsor

入排标准

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)