"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.
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.
Patients suffering from non valvular atrial fibrillation with a contraindication for oral anticoagulation (i.e. bleeding) being eligible of percutaneous implantation of LAA occlusion devices.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Biomarker levels before successful LAA occlusion device implantation||24 hours before intervention|
|Secondary||Biomarker levels after successful LAA occlusion device implantation||mid-term follow up at 6 months|
|Secondary||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|
Biospecimen Retention:Samples With DNA - Two peripheral blood withdraws in EDTA, citrate, ammonium heparin, serum tubes 24 hours before and at mid-term follow up at 6 months after successful LAA occlusion device implantation.