Left Atrial Appendage Occlusion and Biomarker Evaluation "LABEL"

Recruiting

Phase N/A Results N/A

Trial Description

"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.

Detailed Description

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.

Conditions

Trial Population

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.

Outcomes

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.

Sponsors