Prospective, Non-randomized, Safety and Efficacy Study of a New Occluder Design for Minimally Invasive Closure of the Left Atrial Appendage in Patients With Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 8
- 主要终点
- Successful implantation of the Occlutech LAA closure device with less than 7% occurrence of major complications.
研究概览
简要总结
This is a prospective, non-randomized, study of the safety and efficacy of the Occlutech® LAA occluder indicated for percutaneous LAA closure in adult male or female patients with atrial fibrillation. Safety and efficacy will be assessed at day 1, 30 and 90, and after 1 year following implantation of an Occlutech® LAA Occluder.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented paroxysmal, persistent or chronic non-valvular AF
- •Calculated CHA2DS2 -VASC score equal or greater than 2 and/or HAS-BLED score equal or greater than 2
- •Patients eligible or non-eligible for lifelong, oral anticoagulation therapy
- •Life expectancy of at least 1 year
- •Written, informed consent by the patient or her/his legally-authorized representative for participation in the study
排除标准
- •Suspected or known intracardiac thrombus
- •NYHA Class IV CHF
- •Patients who has unstable and intractable angina pectoris
- •ASD and/or atrial septal repair or closure device
- •Recent myocardial infarction within 3 months
- •Severe valvular heart disease, or implanted mechanical valve prosthesis
- •Large PFO with significant atrial septal aneurysm
- •Planned ablation procedure within 30 days of Occlutech LAA occluder® implant
- •Resting heart rate > 110 bpm
- •Allergy to Nitinol, which is a result of nickel and/or titanium allergies
- •Stroke/TIA within the last 30 days
- •Thrombocytopenia, thrombocytosis, leukopenia, or anemia
- •Symptomatic carotid artery disease
- •LVEF < 30%
- •Mitral valve stenosis
研究组 & 干预措施
LAA closure device
Implantation of LAA closure device
干预措施: Implantation of LAA closure device (Device)
结局指标
主要结局
Successful implantation of the Occlutech LAA closure device with less than 7% occurrence of major complications.
时间窗: 12 months
A major complication is defined as an event that results in death, procedure related stroke, systemic embolism, device embolisation, pericardial effusion (cardiac tamponade), or other major bleeding requiring invasive treatment or blood transfusions.
次要结局
未报告次要终点