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临床试验/NCT05014477
NCT05014477Unknown不适用

Device Embolization After Percutaneous Left Atrial Appendage Occlusion: Risk Factors, Approaches and Outcomes

Cardiovascular Center Frankfurt1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2020年9月30日最近更新:
适应症

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

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

发起方
Cardiovascular Center Frankfurt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Horst Sievert

Principle Investigator

Cardiovascular Center Frankfurt

研究点 (1)

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