Device Embolization After Percutaneous Left Atrial Appendage Occlusion: Risk Factors, Approaches and Outcomes
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Catheter-based retrieval of LAA Occluder
研究概览
简要总结
The investigators thought to evaluate risk factors, therapeutic approaches and outcomes after left atrial appendage occluder device embolization (LAAO, either surgical or interventional).
详细描述
The global burden of atrial fibrillation (AF) is high, and AF represents a major cause of morbidity, mortality and health-care expenditure. Thromboembolic stroke may be one of the fatal complications and oral anticoagulation has been the mainstay therapy for decades to mitigate stroke risk. However, in poor candidates for long-term anticoagulation (i.e. high bleeding risk, poor drug tolerance or adherence), non- pharmacological stroke prevention with percutaneous left atrial appendage occlusion (LAAO) is a considerable treatment option.
Occluders are implanted into the left atrial appendage (LAA) but they might dislocate and therefore embolize subsequently. In this case, surgical or percutaneous removal of the device may be indicated. Depending on the patient's status, implanting another device can be an alternative to returning to anticoagulation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients after interventional or surgical left atrial appendage occlusion with device embolization
排除标准
- 未提供
结局指标
主要结局
Catheter-based retrieval of LAA Occluder
时间窗: up to 5 years (after device implantation)
peri-procedural device removal
Need for cardiac surgery
时间窗: In-hospital stay, assessed up to 30 days
Procedural mortality
时间窗: In-hospital stay, assessed up to 30 days
all-cause mortality during the index procedure, any procedure-related death within 30days or during in-hospital stay for the index procedure (if\>30days)
次要结局
- Further complications(up to 5 years (after device implantation))
- Risk factors(up to 30 days (after device implantation))
研究者
Prof. Dr. Horst Sievert
Principle Investigator
Cardiovascular Center Frankfurt
