NCT03147391已完成不适用
Percutaneous Left Atrial Appendage Closure Using the LAmbre Device in Patients With Atrial Fibrillation: a Single-center, Retrospective, Long-term Real-world Study
Shanghai 10th People's Hospital0 个研究点目标入组 66 人开始时间: 2014年4月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 主要终点
- Ischemic stroke
研究概览
简要总结
The study was to retrospectively analyse the efficacy and safety of LAA closure using the LAmbre in our center from April 2014 to November 2015.
详细描述
The study was to retrospectively analyse the efficacy and safety of percutaneous left atrial appendage (LAA) closure using the LAmbre (Lifetech Scientific Co., Ltd., Shenzhen, China) in our center from April 2014 to November 2015. 89.4% has finished the 12-month esophageal ecllocardiogrhy (TEE) examination. The average followup was 2-years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is ≥18 years of age;
- •Chronic atrial fibrillation ≥3 months; paroxysmal, persistent or permanent non-valvular AF;
- •CHADS2-VAS score 2 or higher;
- •Patient can understand the trial purpose, voluntarily join this clinical trial with informed consent;
- •Patient voluntarily completes the follow-up and follow-up inspection in accordance with the clinical trials process.
排除标准
- •A. Clinical exclusion criteria
- •Presence of rheumatic, degenerative or congenital valvular heart diseases,
- •The diameter of left atrial ≥65 mm;
- •LAA size < 12mm or > 30 mm
- •Left atrium has been removed;
- •Heart transplantation patients;
- •Symptomatic patients with carotid artery disease (such as carotid stenosis ≥ 50%);
- •Acute myocardial infarction or unstable angina;
- •Decompensated heart failure (New York Heart Association functional class III-IV);
- •Recent myocardial infarction (< 3 months);
- •Patients with an atrial septal defect or received an atrial septal occluder. The patient has an ablation procedure planned within 30 days of potential LAmbre Occluder implant
- •The patient has a planned cardioversion 30 days post implant of the LAmbre Occluder
- •Patient who after artificial mechanical heart valve replacement operation;
- •Uncontrolled Heart rate ≥ 110 beats / min17) History stroke or TIA within 30 days;
- •Presence of complex aortic plaque(4mm) in ascending aorta;
- •Cardiac tumors or other malignancy with estimated life expectancy u less than 2 years;
- •Have thrombocytopenia (platelet 《105 / μl) or anemia（Hb<10g/dl）;
- •Women who is pregnancy or plan to pregnancy during the trial period;
- •Presence of active sepsis or endocarditis;
- •Patient participated in the other trials;
- •The investigators expect the patient not be able to complete the trial according to requirements.
- •B. Esophageal ultrasonic exclusion criteria
- •Presence of left atrial appendage thrombus;
- •High risk PFO patients(presence of atrial septal aneurysm);
- •Have obvious mitral valve stenosis (the area of mitral valve≤ 2 cm2);
- •Have obvious and unexplained pericardial effusion(≥4 cm2).
- •Presence of complex aortic plague(≥4 mm) in ascending aorta.
结局指标
主要结局
Ischemic stroke
时间窗: up to 5 years
Ischemic stroke
次要结局
- The composite safety and efficacy end-points(up to 5 years)
- Successful sealing of the LAA(up to 5 years)
研究者
Ya-Wei Xu
Director, Head of Cardiology, Principal Investigator
Shanghai 10th People's Hospital
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