NCT04807283进行中（未招募）不适用
A European Trial Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 29
- 试验地点
- 4
- 主要终点
- Confirmation of functional LAA closure as defined by residual peri-device flow ≤ 5mm per TEE
研究概览
简要总结
The objective of this study is to demonstrate safety and effectiveness using a percutaneous Delivery System of the Laminar Left Atrial Appendage Closure System to treat patients with NVAF to reduce the risk of thromboembolism from the left atrial appendage (LAA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Subject must have a documented history of paroxysmal, persistent or permanent nonvalvular atrial fibrillation (AF).
- •Subject must be ≥18 years of age.
- •Subject has a calculated CHA2DS2-VASc score of 2 or greater.
- •Subject must be clinically stable on warfarin (or other anticoagulant) therapy for a minimum of three months.
- •Subject must have at least two International Normalized Ratios (INRs); 2-3, if on Warfarin.
- •Subject is eligible for the defined protocol pharmacologic regimen of anticoagulation and antiplatelet therapy.
排除标准
- •Subject who requires anticoagulation for a condition other than AF.
- •Subject with a New York Heart Association (NYHA) classification equal to IV.
- •Subject with a history of or implanted atrial septal defect (ASD) device or patent foramen ovale (PFO) device that would interfere with the investigational device placement.
- •Subject with valvular disease.
结局指标
主要结局
Confirmation of functional LAA closure as defined by residual peri-device flow ≤ 5mm per TEE
时间窗: 45 days
Freedom from device or procedure related serious adverse events
时间窗: 7 days
次要结局
- Absence of all-cause mortality, major bleeding, ischemic stroke, or systemic embolism(45 days and 6 months)
研究者
研究点 (4)
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