Left Atrial Appendage Occlusion and Biomarker Evaluation

• Conditions: Bleeding; Stroke; Atrial Fibrillation

• Registration Number: NCT02985463
• Lead Sponsor: Universitätsmedizin Mannheim

Brief Summary

"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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2016-12-03
• Study First Submitted QC: 2016-12-03
• Study First Posted: 2016-12-07
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-26
• Last Update Posted: 2020-08-27
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biomarker levels before successful LAA occlusion device implantation	24 hours before intervention

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Medical Centre Mannheim; 🇩🇪 Mannheim, Baden-Württemberg, Germany