NCT02029014Unknown3 期
Evaluation of Safety and Efficacy of the New Generation of Left Appendage Closure With the LAmbre Device in AF Patients Not Suitable for Use of Warfarin
适应症
干预措施
试验速览
- 阶段
- 3 期
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Ischemic stroke
研究概览
简要总结
The aim of this study is to assess the efficacy, safety and performance of LAmbre left atrial appendage closure system in patients with non-valvular atrial fibrillation who cannot be treated with Warfarin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>=18, CHADS2 score>=1
- •Patients cannot be treated long-term with Warfarin
- •Eligible for clopidogrel and aspirin
- •Provide written informed consent and agree to comply with required follow-ups
排除标准
- •Need to take Warfarin
- •Presence of rheumatic, degenerative or congenital valvular heart diseases
- •Early stage or paroxysmal AF
- •Symptomatic patients with carotid artery disease (such as carotid stenosis>=50%)
- •Heart failure NYHA grade IV
- •Recent 30 days stroke or TIA
- •Presence of active sepsis or endocarditis
- •Cardiac tumors or other malignancy with estimated life expectancy <2 years
- •Abnormal blood test; renal disfunction
- •LAA removed or heart implant patients
- •Patients have planned electrophysiological ablation or cardioversion 30 days post implantation of the LAmbre system
- •Patients have history of mechanical prosthesis operation
- •Patients who are pregnant, or desire to be pregnant during the during the study
- •Participation in other trials
- •A known allergy to nitinol
- •Patients will not be able to complete the trial
- •Esophageal ultrasonic exclusion criteria:
- •LAA Ostium <=12mm or >=30mm
- •LVEF <30%
- •Presence of thrombus in the heart
- •High risk PFO
- •Mitral valve stenosis (valve area <2 cm2
研究组 & 干预措施
LAmbre closure system
Experimental
干预措施: LAA closure system (Device)
结局指标
主要结局
Ischemic stroke
时间窗: One year
Successful sealing of the LAA
时间窗: One year
次要结局
- MACCE(One year)
- Device performance assessed by TEE/TTE(One year)
- Complication at puncture site(One year)
- Component events(One year)
研究者
研究点 (1)
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