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【ChiCTR-ONC-13003015】Percutaneous Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation

基本信息
登记号

ChiCTR-ONC-13003015

试验状态

正在进行

药物名称

/

药物类型

/

规范名称

/

首次公示信息日的期

2013-01-22

临床申请受理号

/

靶点

/

适应症

Atrial Fibrillation

试验通俗题目

Percutaneous Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation

试验专业题目

Percutaneous Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation

申办单位信息
申请人联系人
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申请人名称
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联系人邮箱
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联系人邮编

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临床试验信息
试验目的

To assess the effect and safety of Percutaneous Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation.

试验分类
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试验类型

连续入组

试验分期

Ⅳ期

随机化

NA

盲法

/

试验项目经费来源

SK Yee Funding, CUHK

试验范围

/

目标入组人数

80

实际入组人数

/

第一例入组时间

2013-02-28

试验终止时间

1990-01-01

是否属于一致性

/

入选标准

1. Adults above the age of 18; 2. Non-valvular AF, at high risk of stroke and who have experienced serious bleeding events or repeated nuisance bleed events whilst on warfarin or NOACs; 3. Non-valvular AF, at high risk of stroke and who are intolerant of, has significant side effect, or decline to take warfarin or NOACs; 4. Non-valvular AF, at high risk of stroke and who are poorly compliant with warfarin (Time in therapeutic range <60%) or NOACs; 5. Non-valvular AF, at high risk of stroke and who are at high risk of bleeding as evidenced by a high HAS-BLED score.;

排除标准

1. Inability to take Aspirin and Clopidogrel; 2. Inability to give informed consent; 3. Patients unlikely to benefit from the therapy due to a short life expectancy; 4. NYHA 4; 5. LVEF <30%; 6. Moderate-to-severe or worse mitral or aortic valvular regurgitation or stenosis; 7. Suspected or known intracardiac thrombus; 8. Symptomatic carotid disease.;

研究者信息
研究负责人姓名
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试验机构

SK Yee Funding, CUHK

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研究负责人邮编

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示例数据
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research nurse, Division of Cardiology, Department of Medicine & Therapeutics, PWH的其他临床试验

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