Non-pharmacological Prevention of Stroke in Patients With Non-valvular Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Number of patients with Composite of death, stroke, clinically significant bleeding event (>_2 class according to BARC criteria), device leak, device displacement or device thrombosis with the first event for a given patient is taken into account
研究概览
简要总结
Left atrial appendage (LAA) occlude devices are used for over ten years. According to current data efficiency and safety of this approach at least comparable with pharmacological prevention of stroke in patients with non-valvular atrial fibrillation.
However, to date, LAA occluder implantation is not recommended as an alternative for conservative therapy and reserved for patients with contraindications for oral anticoagulants only. In the same time, long-term follow-up of patients enrolled in clinical trials and data from registries showed that LAA occlude device implantation as an alternative to oral anticoagulation could reduce drug load, decrease complexity and cost of treatment and thus improve patients' quality of life, and potentially may reduce the risk of death. The aim of our study is to investigate the risk of all-cause death, stroke, and bleedings in patients with LAA occluder implanted as an alternative to anticoagulant therapy.
Three hundred patients with atrial fibrillation will undergo LAA occluder implantation. For LAA occluder sizing transesophageal echocardiography (TEE), CT and LAA angiography will be performed. The follow-up period will be 36 months. The incidence of all-cause death, stroke, bleeding BARC≥2, device-related complications and QOL will be investigated.
The patients will be followed in the clinic at three and six months, and then at 12, 24 and 36 months, the telephone calls for getting information about endpoints events will be done. Additional in clinic visits will be scheduled if the late complications will be suspected.
TEE will be performed at three and six months to check for device leak, displacement and thrombosis.
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
- •Patient with paroxysmal/persistent/permanent atrial fibrillation
- •CHA2DS2VASc score ≥2 for male and ≥3 for female
- •Without contraindications to anticoagulation therapy
排除标准
- •LAA thrombosis
- •mechanical prosthetic heart valve
- •moderate or severe mitral valve stenosis
结局指标
主要结局
Number of patients with Composite of death, stroke, clinically significant bleeding event (>_2 class according to BARC criteria), device leak, device displacement or device thrombosis with the first event for a given patient is taken into account
时间窗: 36 months
a clinically significant bleeding event is \>_2 class according to Bleeding Academic Research Consortium (BARC) criteria bleeding
次要结局
- device leak and displacement during first 6 months(6 months)
- the percent of patients in whom long -term anticoagulation therapy would add during follow-up(36 months)
- any adverse events during 7 days after LAA occluder implantation(7 days)
- bleeding BARC ≥2(36 months)
- any bleed(36 months)
- device thrombosis during first 6 months(6 months)
- device dislocation(36 months)
- change in QOL SF 36 between baseline and final visit(Assessed at baseline and 6-month follow-up visits)