NCT02230748已完成不适用
Left-Atrium-Appendage Occluder Register - GErmany
Stiftung Institut fuer Herzinfarktforschung4 个研究点 分布在 1 个国家目标入组 643 人开始时间: 2014年7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
- 643
- 试验地点
- 4
- 主要终点
- Safety: clinical events with LAA occlusion
研究概览
简要总结
- Evaluation of safety and effectiveness of implantable LAA occluder in clinical practice
- Indication: For which reasons is the indication for implantation of LAA-Occluder put for patients with atrial fibrillation?
- Safety: How save is the implantation of LAA-Occluders?
- Effectiveness: How effective is implantation of LAA-Occluders in daily clinical practice?
- Concomitant treatment: Which concomitant treatment is prescribed for patients with LAA-Occluder?
详细描述
LAARGE aims to show the care reality of patients whose left atrial appendage (LAA) is closed by an implantable medical device. In particular the following questions should be answered:
- Indication: For which reasons is the indication for implantation of LAA-Occluder put for patients with atrial fibrillation?
- Safety: How save is the implantation of LAA-Occluders (procedural, in hospital and in the long term course)? How frequent are bleeding complications and what is the relation of observed and expected bleeding complications (according HAS-BLED score)?
- Effectiveness: How effective is implantation of LAA-Occluders in daily clinical practice (in hospital and in the long term course)? How frequent are strokes and what is the relation of observed and expected strokes (according CHADS-VASC score)?
- Concomitant treatment: Which concomitant treatment is prescribed for patients with LAA-Occluder?
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
- •Intention to laa occluder
排除标准
- •Missing informed consent
结局指标
主要结局
Safety: clinical events with LAA occlusion
时间窗: 1 year follow-up (optional 2,3,5 years)
Documentation of reasons for LAA Occluder Implantation. Periprocedural and hospital: death, bleeding, pericardial effusion, reanimation, occluder dislocation and further complications. Long term follow-up:: death, bleeding, pericardial effusion, reanimation, occluder dislocation, further complications and patients safety.
次要结局
- Effectiveness: LAA occlusion(1 year follow-up (optional 2,3,5 years))
研究者
研究点 (4)
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