2022-502986-92-00招募中4 期
Anticoagulant Therapy in patients with atrial fibrillation after surgical Left Atrial Appendage Closure: a randomized non-inferiority trial (the ATLAAC trial)
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 1,220
- 试验地点
- 10
- 主要终点
- Stroke, peripheral embolisms and major bleeding events (composite endpoint)
研究概览
简要总结
To investigate the risk of stroke, systemic embolisms and major bleeding events with and without anticoagulant therapy in patients with atrial fibrillation, who have previously undergone surgical left atrial appendage closure
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Previously undergone any type of cardiac surgical procedure including any type of surgical left atrial appendage closure (use of any of the following techniques; amputation and suture closure, stapler closure, non-amputating suture closure or closure with an approved surgical occlusion device (e.g. AtriClip)) according to the National Patient Register (NPR) or the Western Danish Heart Registry (WDHR) from January 1st 2010 till April 1st 2023
- •Documented history of paroxysmal, persistent, or permanent atrial fibrillation or atrial flutter according to the electronic patient record
- •Informed consent
排除标准
- •Not receiving oral anticoagulant therapy (warfarin/DOAC)
- •Patient specific conditions requiring OAC (e.g. mechanical valve, previous pulmonary embolism)
- •Renal impairment (estimated glomerular filtration rate < 30)
- •Allergy to contrast media
- •Pregnancy or breastfeeding
结局指标
主要结局
Stroke, peripheral embolisms and major bleeding events (composite endpoint)
Stroke, peripheral embolisms and major bleeding events (composite endpoint)
次要结局
- Transient ischemic attack
- Ischemic stroke
- Hemorrhagic stroke
- Severity of stroke according to Scandinavian Stroke Scale
- Systemic embolism
- All-cause stroke
- All-cause mortality
- Cardiovascular mortality
- All types of bleeding leading to hospital contact
- Blood transfusions
- Myocardial infarction
- Deep venous thrombosis
- Pulmonary embolism
- Length of the residual stump of the LAA
- Volume of the residual stump of the LAA
- Presence of contrast leakage across the closure line when relevant
- Presence of thrombi in the LAA or the left atrium
- Health-related quality of life scores
研究者
Lars Peter Schødt Riber
Scientific
Odense University Hospital
研究点 (10)
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