Feasibility and Prognostic Role of Percutaneous Left Atrial Appendage Closure in Patients With Heart Failure and Atrial Fibrillation at High Risk for Cerebrovascular Events
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 主要终点
- procedural success
研究概览
简要总结
Study hypotheses is that in patients with heart failure and atrial fibrillation, reduced left atrial appendage (LAA) emptying velocities leads to LAA thrombus formation therefore a higher rate of stroke and embolism are observed even on oral anticoagulants.
Therefore The left atrial appendage closure (LAAC) procedure's benefit in patients with an impaired left ventricular ejection fraction (LVEF) has to be investigated So the study is to assess the safety and prognosis of left atrial appendage closure (LAAC) in patients with heart failure in preventing thromboembolic events, bleeding and all-cause mortality.
Patients will be divided into to groups, one group includes patients with no evidence of heart failure, and another group including patients with previous history of or with an evidence of with heart failure.
详细描述
Patients selection All patients underwent left atrial appendage closure in Assiut university in the period from January 2014 to December 2019 will be included.
Inclusion criteria In this retrospective cohort study, atrial fibrillation patients with previous major bleeding, bleeding predisposition or contraindications for oral anticoagulants scheduled for transcatheter left atrial appendage closure are included.
Methods In this retrospective cohort study
- All patients with previous major bleeding or a bleeding predisposition scheduled for transcatheter LAAC in Assiut university in the period from January 2014 to December 2019 will be included.
- All devices used in for LAAC in this period will be included (WATCHMAN, Amulet, LARIAT and Lambre)
- CHA2DS2-VASC, CHADS, HAS-BLED scores will be calculated for all patients.
- Patients will be divided into to groups, one group includes patients with no evidence of heart failure, and another group including patients with previous history of or with an evidence of with heart failure.
- Heart failure will be defined as patients with left ventricular ejection fraction ≤ 35%.
- New York Heart Association (NYHA) classification will be determined for all patient graded from I-IV.
- Both groups will be compared regarding procedural success (Procedural success is defined as deployment and release of the left atrial appendage closure device into the LAA with peri-device leak < 5 mm), the absence of any complication related to the intervention, major and minor bleeding, all-cause mortality and efficacy of the device to prevent stroke, transient ischemic attack, systemic embolization during follow-up.
- Device related thrombus (DRT) will be compared in both groups according to the results of transesophageal echo (TOE) 6 weeks post procedure.
Primary endpoint
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
- •In this study,
- •Atrial fibrillation patients with previous major bleeding.
- •Atrial fibrillation patients with previous bleeding predisposition
- •Atrial fibrillation patients with previous contraindications for oral anticoagulants scheduled for transcatheter left atrial appendage closure are included.
排除标准
- •Patients having no data for follow up after the procedure
结局指标
主要结局
procedural success
时间窗: 6 weeks post procedure
procedural success (Procedural success is defined as deployment and release of the left atrial appendage closure device into the LAA with peri-device leak \< 5 mm) The study will assess the rate of procedural success in both groups of the study.
the absence of any complication related to the intervention
时间窗: 6 months post intervention
Post procedural Complications including cerebrovascular stroke, bleeding and all cause mortality will be compared in both groups of the study to assess the prognosis of the procedure in these groups.
次要结局
未报告次要终点
研究者
Mohamed Osman Abdelhamead
Principal Investigator
Assiut University