A Study to Evaluate the Safety and Effectiveness of the Left Atrial Appendage Closure Therapy Using BSJ003W for Patients With Non-valvular Atrial Fibrillation at Increased Risk of ThromboEmbolism in Japanese Medical Environment (SALUTE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 20
- 主要终点
- Number of Participants With Complications; One of the Following Events
研究概览
简要总结
The purpose of this study is to confirm the safety and effectiveness of the BSJ003W in Japanese patients with non-valvular atrial fibrillation at increased risk of thromboembolism in Japanese Clinical environment
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is Japanese, over 20 years old and provides written informed consent to participate in the trial
- •The subject has documented paroxysmal, persistent or permanent non-valvular atrial fibrillation
- •The subject has a calculated CHA2DS2-VASc score of 2 or greater and is recommended for long-term oral anti-coagulation therapy
- •The subject is deemed by their physicians to be suitable for anticoagulant therapy and have an appropriate rationale to seek a non-pharmacologic alternative to warfarin
- •The subject is eligible to come off warfarin therapy if the LAA (left atrial appendage) is sealed (i.e. the subject has no other conditions that would require warfarin therapy).
排除标准
- •The subject has a prior stroke (ischemic or hemorrhagic) or transient ischemic attack within the 90 days prior to consent
- •The subject has had a myocardial infarction either non-ST elevation or ST elevation myocardial infarction within 90 days prior to consent with or without intervention
- •The subject had or is planning to have any cardiac (e.g. cardioversion, coronary angiogram, percutaneous coronary intervention, cardiac ablation, etc.) or non-cardiac invasive or surgical procedure (e.g. cataract surgery, endoscopy, etc.) within 30 days prior or 45 days after the BSJ003W implant
- •The subject has a history of atrial septal repair or has an atrial septal defect/persistent foramen ovale device
- •The subject has an implanted mechanical valve prosthesis in any position
- •The subject currently New York Heart Association class IV congestive heart failure
- •The subject is contraindicated to aspirin
- •The subject is contraindicated or seriously allergic to thienopyridine
- •The subject is of childbearing potential and is, or plans to become pregnant during the time of the study
- •The subject is not able and willing to return for required follow-up visits and examinations
- •Subjects who are currently enrolled in another investigational study (of which primary endpoint follow-up have not been completed yet).
- •The subject has other reason not to be eligible for this study per investigators' discretion.
结局指标
主要结局
Number of Participants With Complications; One of the Following Events
时间窗: Between the time of implant and within 7 days following the procedure or by hospital discharge, whichever is later
All-cause death, ischemic stroke, systemic embolism, or device- or procedure- related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, arteriolar-venular fistula repair, or other major endovascular repair.
Number of Participants With One of the Following Events: Stroke (All/ Ischemic/ Hemorrhagic), Systemic Embolism and Cardiovascular(CV) Death (Including Unexplained Cause)
时间窗: 24-month
The occurrence of composite events including stroke (all/ ischemic/ hemorrhagic), systemic embolism and cardiovascular death (including unexplained cause) till 6-month post implant
The Rate of Effective Left Atrial Appendage (LAA) Closure
时间窗: 45-day, 6-month, 12-month
The effective LAA closure is defined as peri-device flow \<= 5mm demonstrated by TEE. TEE measurements will be assessed by an independent Core Laboratory.
次要结局
- Number of Participants With Ischemic Stroke or Systemic Embolism(24-month)
- Number of Participants With Major Bleeding(24-month)
- Number of Participants With Clinically Overt Non-fatal Bleeding(24-month)