Left Atrial Appendage Occlusion and Biomarker Evaluation (LABEL)

Universitätsmedizin Mannheim

Status: Unknown

Conditions: Atrial Fibrillation; Stroke; Bleeding

Study type: Observational

Funder types: Other

Identifiers

NCT02985463

2014-402M-MA-§ 23b MPG

Details and patient eligibility

About

"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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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