Prospective, Randomized, Controlled, Unblinded, International, Multicentre, Parallel Two Group Trial of Left Atrial Appendage Closure in Patients With Non-valvular Atrial Fibrillation and End-stage
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 430
- 试验地点
- 2
- 主要终点
- "Net clinical benefit"
研究概览
简要总结
In the proposed event driven trial, LAA closure devices will be compared in a 1:1 randomization to best medical care in AF patients at high risk of stroke and bleeding with ESKD. The trial will allow the use of the CE marked and clinically used LAA device Amplatzer Cardiac Plug and/or Amulet and all approved medical therapies in AF patients with ESKD including vitamin-K antagonists (VKA), NOACs as well as antiplatelet agents or no anticoagulation in excessive bleeding risk.
详细描述
The purpose of the current study is to evaluate the clinical benefit of percutaneous catheter-based left atrial appendage (LAA) closure in patients with non-valvular atrial fibrillation (NVAF) and end-stage renal failure.
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
- •Age ≥ 18 years
- •Ability to give informed consent
- •Documented NVAF (paroxysmal, persistent, or permanent)
- •CHA2DS2VASc risk score ≥2
- •Chronic kidney disease KDOQI stage 5 (eGFR <15 ml/min/1.73m2) with or without hemodialysis
排除标准
- •Absolute contraindication to aspirin and/or clopidogrel
- •Comorbidities other than AF requiring chronic (N)OAC therapy e.g. mechanical heart valve prosthesis
- •Present LAA thrombus
- •Mobile aortic atheroma
- •Age ≤18 years
- •Patients presenting with pregnancy
- •Patients without informed consent
- •Participation in another trial
- •Expected life expectancy <2 years
结局指标
主要结局
"Net clinical benefit"
时间窗: Day 0
"Net clinical benefit", defined as, time to first stroke (including ischemic or hemorrhagic strokes), systemic embolism, cardiovascular or unexplained death or major bleeding (BARC 3-5)
次要结局
未报告次要终点
研究者
Prof. Dr. med. Ingo Eitel
Director
University of Luebeck