Stand-Alone Left Atrial Appendage Occlusion for throMboembolism Prevention in Nonvalvular Atrial fibrillatioN DiseasE Registry (SALAMANDER)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Safety and efficacy
研究概览
简要总结
This prospective nationwide registry aims to assess the durability of left atrial appendage occlusion when performed via totally thoracoscopic, percutaneous and hybrid- minimally invasive approaches and collect information on possible adverse events.
详细描述
Stand-Alone Left Atrial appendage occlusion for throMboembolism prevention in Nonvalvular Atrial Fibrillation DiseasE Registry (SALAMANDER) will commence in 37 heart surgery centers across Poland and has no limit of patient recruitment. Included in the registry will be all >18 y.o. patients with AF and high risk of thromboembolic and bleeding complications defined by CHA2DS2-VASc Score > 2 and HASBLED score of > 2 referred to stroke prevention who do not require an open chest surgery for other reasons. The primary outcome will be the number of perioperative (in-hospital/30-days) complications associated with LAA closure device placement and intraoperative success of exclusion of LAA as assessed by transesophageal echocardiography. Secondary outcomes will be major adverse cardiac and cerebrovascular events (MACCE, combined endpoint of death, acute heart failure, myocardial infarction and stroke); pulmonary complications and any complications connected with surgical intervention. AF-related risks, including stroke/systemic thromboembolism and bleeding outcomes, will be assessed. Medical history, risk factors, demographic information and management will be collected at baseline, and clinical events during 1 -year follow-up will be recorded. Follow-up will be conducted for at least 1 year and then annually thereafter till year 5th post-op.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •patients aged ≥18 years;
- •ECG/Holter diagnosis of AF;
- •Previous stroke or systemic thromboembolic complications;
- •High risk of thromboembolic complications - CHA2DS2-VASc Score ≥ 2;
- •HASBLED score of > 2;
- •Contraindications to oral anticoagulation or Complications of oral anticoagulation;
- •(8) Acceptable surgical candidate, including use of general anesthesia; (9) patient adherence to the study and patient Informed Consent Form has been signed
排除标准
- •No ECG with AF recorded (12-lead ECG, Holter recording, external event recorder or implantable loop recorder) or only atrial flutter recorded,
- •Significant valve disease or coronary multivessel artery lesions requiring operation;
- •Stroke/cerebrovascular accident (CVA) within previous 30 days;
- •Critical preoperative state;
- •participation in a clinical trial
- •patient refusal
- •Registry imposes intraoperative exclusion criteria to otherwise enrolled patients:
- •Presence of thrombus in the LA or LAA
- •LAA tissue with significant adhesions (as evaluated by the surgeon) making AtriClip® placement overly risky.
- •Previous cardiac operations (e.g., CABG, heart transplant, valvular replacement) making LARIAT placement overly risky.
- •Patients with a previous atrial septal defect with surgical or transcatheter closure making Watchman placement overly risky.
- •Right-sided heart failure;
- •Symptomatic carotid artery disease;
- •active systemic infection.
结局指标
主要结局
Safety and efficacy
时间窗: 30 days
The number of peri-operative (in-hospital/30-days) complications associated with LAA closure device placement and intraoperative success of exclusion of LAA as assessed by transesophageal echocardiography
次要结局
- Long-term sequelae(5 years)
研究者
Mariusz Kowalewski
PhD, M.D.
Nicolaus Copernicus University