NCT02985463Unknown不适用
Left Atrial Appendage Occlusion and Biomarker Evaluation
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Biomarker levels before successful LAA occlusion device implantation
研究概览
简要总结
"Left Atrial Appendage Occlusion and Biomarker Evaluation" (LABEL) is a single-center, prospective and observational study evaluating changes of the expression of biomarkers in eligible patients before and after percutaneous implantation of a left atrial appendage (LAA) occlusion device at mid-term follow-up.
详细描述
This study will evaluate the changes of different types of biomarkers before and after successful percutaneous implantation of an LAA occlusion device.
Biomarker evaluation will focus on blood derived biomarkers including neurohormones, proteins, cytokines, microRNAs and metabolomics.
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
- •non valvular atrial fibrillation, that makes anticoagulation to prevent embolic stroke from the LAA
- •contraindication for the therapy with oral anticoagulants:
- •refusal to take oral anticoagulation
- •HasBled-score more than 3
- •prior bleedings under oral anticoagulation
排除标准
- •under 18 years
- •severely reduced left atrial function
- •mechanical heart valve
- •pulmonary embolism
- •deep vein thrombosis
- •myocardial infarction within the last 3 months
- •electrical cardioversion within 30 days after potential occluder implantation
- •atrial septum defect or interventional/surgical occlusion of ASD
- •status after heart transplant
- •symptomatic carotid artery stenosis
- •transient ischemic attack (TIA) or stroke within last 30 days
- •intracerebral bleeding within the last 2 months
- •acute infection
- •existing or planned pregnancy
结局指标
主要结局
Biomarker levels before successful LAA occlusion device implantation
时间窗: 24 hours before intervention
次要结局
- Biomarker levels after successful LAA occlusion device implantation(mid-term follow up at 6 months)
- Changes of biomarker expression before and after device implantation over mid-term follow-up, depending of complete, incomplete occlusion, imaging data (transesophageal echocardiography, computed tomography)(mid-term follow up at 6 months)
研究者
Michael Behnes
Dr. med
Universitätsmedizin Mannheim
研究点 (1)
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