Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation: Latin America Registry on WatchmanTM Outcomes in Real Life
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Incidence of Periprocedural complications
研究概览
简要总结
Left atrial appendage (LAA) occlusion with WatchmanTM has emerged as viable alternative to anticoagulation therapy in randomized controlled trials. The device has FDA approved since 2015 and the firsts Latin American cases were performed in 2012. However, there is no real world data from Latin American experience in terms of success and outcomes.
详细描述
Approximately 450 subjects will be enrolled in the study. Up to 50 sites in Latin America will participate in the study.
Primary analyses may include, but will not be limited to, the following: procedural complications, incidence of stroke and death. Descriptive statistics will be used for baseline, procedure and follow-up data collected through the registry.
Clinical history of each patient will be analyzed for a period of 6 months after the procedure according the standard practice at the enrolling centers. There will be no additional visits, nor procedures, for subjects in the registry.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who were eligible for a WatchmanTM device implantation according to current international and local guidelines and per physician and institution discretion.
排除标准
- •Patient who were currently enrolled in another investigational study or registry that would directly interfere with the current study aims.
结局指标
主要结局
Incidence of Periprocedural complications
时间窗: At implant
Pericardial effusion, stroke, device embolization and bleeding
Incidence of Stroke
时间窗: 6 months follow up
Stroke
Incidence of Death
时间窗: 6 months follow up
Cardiovascular and no cardiovascular death
次要结局
未报告次要终点
研究者
Luis Cressa
Interventional Cardiologist
Centro Medico Docente la Trinidad