Evaluation of the Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 9
- 主要终点
- SEPIOLA System Safety
研究概览
简要总结
The study is designed to evaluate the safety and performance of the ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device in Patients with non-valvular Atrial Fibrillation, who are at increased risk for stroke, and that cannot take, or have a reason to seek an alternative, to long-term anticoagulation therapy.
Potential patients who are candidates for LAA closure will be screened to confirm that all inclusion/exclusion criteria are met, with final eligibility confirmation on day of procedure.
All enrolled subjects who went through the procedure will be followed during the procedure to hospital discharge.
Additional follow up time points are scheduled at 45 days, 6 months and 12 months post procedure.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •calculated CHA2DS2-VASc score of 2 or greater.
- •The subject is non-eligible or have an appropriate rationale to seek a non-pharmacologic alternative to chronic oral anticoagulants.
- •documented non-valvular atrial fibrillation
- •Subject suitable for vascular/cardiac intervention procedure
- •suitable LAA anatomical measurements for study device
排除标准
- •Subject who requires anticoagulation for a condition other than AF.
- •NYHA classification IV.
- •Complex congenital heart disease.
- •Presence of circumflex coronary artery stent.
- •The subject has a prosthetic valve in any position.
- •atrial septal defect closure or has an ASD/PFO device.
- •presence of intracardiac thrombus.
- •Any cardiac surgery in the past
- •LVEF < 35%.
- •intracardiac thrombus
- •moderate or severe mitral valve stenosis
结局指标
主要结局
SEPIOLA System Safety
时间窗: 7 days, 45 days and 6 months post procedure
Device and Investigational Procedure Related Serious Adverse Events (SAE)
次要结局
- Device success(45 days)