Deutsches Ablations-Qualitätsregister
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20,663
- 试验地点
- 9
- 主要终点
- Characterize consecutive patients with electrophysiological ablation in daily hospital routine in Germany.
研究概览
简要总结
The goal of this register is the documentation of the success as well as of the complications regarding interventional therapy of cardiac arrhythmia by catheter ablation. This is the necessary basis for quality management and development of possible improvements of catheter ablation.
详细描述
The interventional therapy of heartbeat disturbances by means of catheter ablation makes the curative treatment possible of numerous tachycardiac arrhythmics. By this crucial improvement of the supply of patients and its quality of life a genuine healing of a multiplicity of heartbeat disturbances became possible. Especially within the range of the ablation treatment there are relatively few con-trolled studies, which would give a broad collection of the results of the catheter ablation in the different indication areas.
Aim of the registry:
Documentation of indication, hospital course and complications during long term follow-up of patients with catheter ablation
Design:
Prospective, multicenter registry; FU-duration 12 months.
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 ablation register will include all consecutive patients with a performed or attempted electrophysiological ablation
排除标准
- •Missing signed informed consent
结局指标
主要结局
Characterize consecutive patients with electrophysiological ablation in daily hospital routine in Germany.
时间窗: 01/06/2008-12/31/2011
次要结局
- Documentation of hospitalizations during the first year after ablation(01/06/2008-12/31/2011)
- Documentation of medication therapy after 12 months(01/06/2008-12/31/2011)
- Documentation of medication therapy at hospital discharge(01/06/2008-12/31/2011)
- Documentation of needed interventions (implantation of either pacemaker, ICD or CRT, revascularization, a further ablation) during the first year after ablation(01/06/2008-12/31/2011)
- Documentation of hospital mortality, serious but non-fatal complications (stroke, TIA, myocardial infarction, resuscitation), and complications caused by bleedings (serious as well as moderate)(01/06/2008-12/31/2011)
- Documentation of the technical implementation of ablation and the success of the intervention(01/06/2008-12/31/2011)
- Documentation of further necessary interventions after the initial ablation during hospital stay(01/06/2008-12/31/2011)
- Documentation of the 1-year mortality, serious but non-fatal complications (stroke, TIA, myocardial infarction, resuscitation), of heavy bleedings, of phrenicus pareses, PV-stenoses, or fistulas(01/06/2008-12/31/2011)
- Documentation of the absence of relapse and of symptomatology after one year(01/06/2008-12/31/2011)