Hemostatic Activity Following Left Atrial Appendage Occlusion
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Change in coagulation activity
研究概览
简要总结
The primary objective of this study is to prospectively investigate hemostatic activity following transcatheter left atrial appendage occlusion (LAAO).
详细描述
This is a prospective cohort study of patients undergoing transcatheter LAAO at Aarhus University Hospital. Hemostatic consequences following device implantation will be evaluated using blood samples collected pre- and post-procedurally, and serially during three months follow-up in 135 LAAO patients. Platelet function and characteristics, overall activation of the extrinsic coagulation pathway and the intrinsic contact activation pathway, as well as endothelial response to implantation, will be assessed through a wide range of biochemical analyses. Patients will serve as their own controls, with a final control blood sample collected at three-months follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Atrial fibrillation (paroxysmal, persistent, or permanent)
- •Admitted and eligible for LAAO
- •Signed written consent
排除标准
- •Known hereditary bleeding disorders (i.e. Hemophilia A and B, Von Willebrand disease)
- •Platelet count < 75 x 109/ml
结局指标
主要结局
Change in coagulation activity
时间窗: 7 days, 14 days, 90 days
Coagulation activity as measured by prothrombin fragment 1+2
次要结局
- Non-procedural bleeding events(7 days, 14 days, 90 days)
- Additional measures of changes in coagulation and contact activation(7 days, 14 days, 90 days)
- Radiographical evidence of device endothelization(7 days, 14 days, 90 days)
- Change in platelet activity(7 days, 14 days, 90 days)
- Change in endothelial activation and response(7 days, 14 days, 90 days)
- Radiographically confirmed device-related thrombosis(7 days, 14 days, 90 days)