Efficacy of Left Atrial Appendage Closure After Gastrointestinal Bleeding
试验速览
- 阶段
- 3 期
- 入组人数
- 120
- 试验地点
- 8
- 主要终点
- Combined overall mortality, major bleeding, stroke or procedure-related complications
研究概览
简要总结
Patients with atrial fibrillation requiring anticoagulation treatment are at high risk of gastrointestinal bleeding. The investigators propose the percutaneous stop the oral anticoagulation and closure of the left atrial appendage with the Amplatzer ® system in patients receiving anticoagulant therapy for atrial fibrillation without associated valvular heart disease, to reduce significantly the risk of stroke while minimizing the risk of bleeding in a group of patients with high risk for both events.
ELIGIBLE trial(Left atrial appendage Efficacy of GastroIntestinal Bleeding after closure) is a prospective, multicentric and randomized (2 to 1) trial, comparing percutaneous closure of atrial appendage left versus standard treatment with oral anticoagulants in patients with history of gastrointestinal bleeding and high embolic risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •documented atrial fibrilation (paroxysmal or permanent) without significant heart valve disease
- •> 18 years
- •Classic oral anticoagulation(INR at therapeutic levels: 2-3) or New oral anticoagulants
- •CHA2-DS2-VASC score ≥ 3
- •prior digestive bleeding without any treatable cause
- •Informed consent.
排除标准
- •contraindication to further treatment with dual antiplatelet therapy (aspirin + clopidogrel)
- •Intracardiac thrombus
- •significant carotid disease
- •Cardioversion scheduled within 30 days following the implantation
- •AF not controlled by FVM> 100 bpm
- •AF secondary to surgery or ablation
- •thrombosis in patients <40 years
- •chronic renal insufficiency with Cr clearance <30 ml 2
- •left appendage sizeappendage with inlet <12.6 mm or > 28.5 (ETE)
- •depth of the appendage <10mm in the TEE
结局指标
主要结局
Combined overall mortality, major bleeding, stroke or procedure-related complications
时间窗: 1 year
The primary end point will be at one year the combined overall mortality, major bleeding, stroke or procedure-related complications. 1. Mortality from any cause 2. Severe bleeding defined according to VARC criteria 3. Ischemic stroke or hemorrhagic stroke at 12 months. 4. Complications related to the procedure: include: * device embolization * severe pericardial effusion with hemodynamic compromise that requires drainage * Device thrombosis * cardiac perforation * major local complications (according to definitions of VARC)
次要结局
未报告次要终点
研究者
Victoria Martin Yuste
MD, PhD
Hospital Clinic of Barcelona