The Fourth Left Atrial Appendage Occlusion Study (LAAOS-4)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4,000
- 试验地点
- 223
- 主要终点
- Ischemic stroke or systemic embolism
研究概览
简要总结
LAAOS-4 aims to determine if catheter-based endovascular left atrial appendage occlusion prevents ischemic stroke or systemic embolism in participants with atrial fibrillation, who remain at high risk of stroke, despite receiving ongoing treatment with oral anticoagulation.
详细描述
LAAOS-4 is a multicentre, prospective, open-label, randomized controlled trial with blinded assessment of endpoints (PROBE) to determine if catheter-based endovascular left atrial appendage occlusion prevents ischemic stroke or systemic embolism in participants with atrial fibrillation, who remain at high risk of stroke, despite receiving ongoing treatment with oral anticoagulation.
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
- Single (Outcomes Assessor)
盲法说明
Events Adjudication Committee is blinded to intervention assignment.
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
- •(a) Persistent or permanent atrial fibrillation OR (b) Paroxysmal atrial fibrillation in participants with a history of ischemic stroke or systemic embolism
- •Increased risk of stroke, defined as a CHA2DS2-VASc stroke risk score of ≥
- •[Note: the acronym CHA2DS2-VASc stands for congestive heart failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled), vascular disease, age 65 to 74 and sex category (female).]
- •Treatment with oral anticoagulants (Vitamin K agonist or factor Xa inhibitor) for at least 90 days prior to enrollment, AND no documented plan to discontinue treatment with oral anticoagulants for the expected duration of the trial.
排除标准
- •Age < 18 years
- •Current left atrial appendage thrombus
- •Prior left atrial appendage occlusion or removal (surgical or percutaneous)
- •Prior percutaneous atrial septal defect or patent foramen ovale closure
- •Prior atrial fibrillation ablation unless evidence of recurrent qualifying atrial fibrillation present at least 30 days following ablation
- •Planned atrial fibrillation ablation within 90 days of enrollment
- •Individuals being treated with direct thrombin inhibitors
- •Women of childbearing potential unless they agree to employ effective birth control methods throughout the study
- •Anticipated life-expectancy of < 2 years
- •Patient unable or willing to give informed consent
研究组 & 干预措施
WATCHMAN device
Participants will undergo endovascular left atrial appendage occlusion with the WATCHMAN device
干预措施: WATCHMAN device (Device)
Standard Care
Participants will receive local, standard medical care
结局指标
主要结局
Ischemic stroke or systemic embolism
时间窗: The study duration is event-driven. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).
The primary efficacy variable is the time from randomization to first occurrence of any of the components of the composite outcome (adjudicated) over the duration of follow-up, including: * Ischemic stroke (Strokes of undetermined etiology will be treated as ischemic stroke) * Systemic embolism
次要结局
- Montreal Cognitive Assessment (MoCA) Score(Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).)
- All-cause mortality(Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).)
- All-cause stroke or systemic embolism(Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).)
- New disabling ischemic strokes(Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).)
- All-cause stroke, systemic embolism, or transient ischemic attack (TIA)(Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).)
- Cardiovascular mortality(Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).)