Stand-Alone Thoracoscopic Epicardial Left Atrial Appendage Occlusion With AtriClip® Device for Thromboembolism Prevention in Nonvalvular Atrial Fibrillation - the Polish Nationwide Registry.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Perioperative complications
研究概览
简要总结
Polish multicenter registry to assess safety and durability of totally thoracoscopic left atrial appendage occlusion for stroke prevention in atrial fibrillation.
详细描述
The THORACS-LAAO Registry is the Polish multi-institutional registry of the consecutive patients with atrial fibrillation assigned for the totally thoracoscopic left atrial appendage occlusion (LAAO) for stroke prevention with designed epicardial clip AtriClip®. The registry has no limit of the number of patient included. Patients will be followed up with transoesophageal echocardiography at 6-12 months to assess the durability of left atrial appendage (LAA) oclusion and collect the informations about possible adverse events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age >18 years
- •Lone atrial fibrillation
- •Previous stroke or systemic thromboembolic complications
- •High risk of thromboembolic complications assessed with CHA2DS2-VASc Score >2
- •High bleeding risk assessed with HASBLED score =>
- •Contraindications to oral anticoagulation
- •Complications of the oral anticoagulation
- •Acceptable surgical candidate, including use of general anaesthesia
排除标准
- •Patient refusal
- •Significant valve disease or coronary multi-vessel artery lesions requiring surgery
- •Stroke/cerebrovascular accident (CVA) within previous 30 days
- •Critical preoperative state
- •Intra-Operative Exclusion Criteria
- •Presence of thrombus in the left atrium or LAA as documented on intra-operative transesophageal echocardiography
- •LAA tissue with significant adhesions (as evaluated by the surgeon) carries AtriClip placement overly risky.
研究组 & 干预措施
Included
The consecutive patients with atrial fibrillation assigned to totally thoracoscopic stand-alone left atrial appendage occlusion using AtriClip® for stroke prevention.
干预措施: AtriClip™ LAA Exclusion System (Device)
Included
The consecutive patients with atrial fibrillation assigned to totally thoracoscopic stand-alone left atrial appendage occlusion using AtriClip® for stroke prevention.
干预措施: Oral anticoagulation therapy (Drug)
结局指标
主要结局
Perioperative complications
时间窗: First 5 postoperative days
Number of perioperative complications associated with AtriClip placement
Intraoperative success of exclusion of LAA.
时间窗: Intraoperatively
Successful exclusion of LAA is defined as no communication between LAA and LA and \< 5 mm LAA remnant measured by intraoperative transesophageal echo with Doppler.
次要结局
- Pulmonary complications.(Up to 30 days post operation)
- Major adverse cardiac and cerebrovascular events (MACCE)(5 years)
- Any complications connected with surgical intervention(Up to 30 days post operation)
研究者
Piotr Suwalski, PhD
Doctor of Philosophy
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland