NCT04429646已完成不适用
A Prospective, Multicenter, Randomized, Active Controlled, Clinical Trial of the LAMax LAA Closure System Compared to the Watchman® LAAC Device for Subjects With Non-valvular Atrial Fibrillation to Reduce the Risk of Ischemic Stroke
Second Affiliated Hospital, School of Medicine, Zhejiang University13 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2019年4月20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
- 236
- 试验地点
- 13
- 主要终点
- Ischemic stroke, TIA, or Systemic embolism
研究概览
简要总结
This is a prospective, multicenter, randomized, active controlled, clinical trial to evaluate the safety and effectiveness of the LAMax Left Atrial Appendage (LAA) Closure System.
详细描述
This is a prospective, multicenter, randomized, active controlled, clinical trial to evaluate the safety and effectiveness of the LAMax Left Atrial Appendage Closure (LAAC) System. Subjects with non-valvular Atrial Fibrillation will be randomized in a 1:1 ratio to the Experimental Treatment Arm (LAMax LAAC system) or the Control Arm (Watchman LAAC system, Boston Scientific Inc., USA). The trial is designed to demonstrate that safety and effectiveness of the LAMax device are non-inferior to the Watchman device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients ≥ 18 years old with non-valvular atrial fibrillation (AF) and CHA2DS2-VASc ≥2
- •There is one of the following: (1) Not suitable for long-term standard anticoagulation treatment; (2) On the basis of long-term standardized anticoagulant therapy with warfarin, stroke or embolism still occurred; (3) HAS-BLED ≥
- •Provide written informed consent and agree to comply with required follow-ups.
排除标准
- •. Patients with other diseases other than AF who need long-term warfarin anticoagulation therapy;
- •. Those who need selective cardiac surgery;
- •. Heart failure NYHA grade IV;
- •. AF caused by rheumatic valvular disease, degenerative valvular disease, congenital valvular disease, severe mitral stenosis, aortic stenosis, or other valvular diseases;
- •. The early onset of AF and paroxysmal AF with definite causes, such as secondary to coronary artery bypass grafting (CABG), hyperthyroidism;
- •. Patients with symptomatic carotid artery disease (such as carotid stenosis > 50%);
- •. Patients with acute myocardial infarction, unstable angina, or recent myocardial infarction < 3 months;
- •. Stroke or TIA within 30 days;
- •. Bleeding disease, coagulation-related diseases, and active peptic ulcer;
- •. Active endocarditis, vegetations, or other infections causing bacteremia or sepsis;
- •. Conditions may lead to difficulty in testing or significantly shorten the life expectancy of patients (< 1 year);
- •. Pregnant, lactating or planned pregnancy during the trial;
- •. Patients who have not reached the end of other clinical trials of drug or device;
- •. Hematological abnormality (WBC < 3 × 109 / L, HB < 90g / L, or platelet count < 50 × 109 / L or > 700 × 109 / L));
- •. Renal insufficiency (creatinine > 3.0mg/dl or 265.2umoi / L), and / or advanced renal diseases requiring dialysis;
- •. Severe liver dysfunction (AST / ALT is 5 times higher than the upper limit of normal value, or total bilirubin is 2 times higher than the upper limit of normal value);
- •. The investigator believes that the patient is not suitable to participate in the clinical trial.
- •. Left atrial appendage has been removed, post heart transplantation, post atrial septal repair, or post occluder implantation;
- •. Radiofrequency ablation in 30 days before and after the implantation of LAA occluder;
- •. Cardioversion within 30 days after the implantation of LAA occluder;
- •. Post prosthetic heart valve replacement;
- •. Allergic to or contraindication to metal nickel alloy, aspirin, clopidogrel, contrast agent, heparin and other anticoagulants, etc;
- •. Patients who have placed other instruments in the cardiovascular cavity and are unable to place the LAA occluder;
- •. LVEF（left ventricular ejection fraction ）<35%；
- •. Clear thrombus is found in the heart before device implantation;
- •. TEE examination: refer to Watchman LAAC requirement to measure the orifice diameter of LAA, the maximum diameter is less than 17 mm, or more than 31 mm;
- •. Patent foramen ovale with high risk;
- •. mitral stenosis with a valve area ≤ 2 cm2;
- •. left atrial diameter > 65mm, or pericardial effusion more than a small amount, the depth of local effusion > 10 mm;
- •. Contraindications to X-ray, or not suitable for TEE examination.
结局指标
主要结局
Ischemic stroke, TIA, or Systemic embolism
时间窗: 12 months post-implantation
A composite rate of ischemic stroke, TIA or systemic embolism.
Successful sealing of the LAA
时间窗: 12 months post-implantation
A composite rate of successful sealing of the left atrial appendage (defined as residual flow ≤ 5 mm) at the 12-month visit documented by transesophageal echocardiogram (TEE).
次要结局
- All stroke, systemic embolism, or cardiovascular/unexplained death(12 months post-implantation)
- Success rate of device collapse and reposition during implantation procedure(0 day)
- Incidence of MACCE events(12 months post-implantation)
- Major Bleeding post-device implant(12 months post-implantation)
- Device performance post-implantation(12 months post-implantation)
- Device success rate(0 day)
- Rate of cardiac temponade during implantation procedure(0 day)
- Success rate of delivering an occlusion device to the LAA by the delivery system(0 day)
- Success rate of withdrawing a delivery system after LAAC(0 day)
- Perioperative clinical success rate(7 days post-implantation)
研究者
Jian'an Wang,MD,PhD
President of the Second Affiliated Hospital, School of Medicine, Zhejiang University & Chief of Cardiology
Second Affiliated Hospital, School of Medicine, Zhejiang University
研究点 (13)
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