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
试验速览
- 阶段
- 3 期
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Successful sealing of the LAA
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
结局指标
主要结局
Successful sealing of the LAA
时间窗: One year
Ischemic stroke
时间窗: One year
次要结局
- Component events(One year)
- MACCE(One year)
- Device performance assessed by TEE/TTE(One year)
- Complication at puncture site(One year)
研究者
研究点 (1)
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