Left Atrial Appendage Occlusion and Biomarker Evaluation

Stroke Clinical Trial

— LABEL  

Official title:

Left Atrial Appendage Occlusion and Biomarker Evaluation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02985463
• Other study ID #: 2014-402M-MA-§ 23b MPG
• Status: Active, not recruiting
• Start date: June 2014
• Est. completion date: December 2021

Study information

• Verified date: August 2020
• Source: Universitätsmedizin Mannheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Bleeding
• Stroke

Locations

Country	Name	City	State
Germany	University Medical Centre Mannheim	Mannheim	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsmedizin Mannheim

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Behnes M, Akin I, Sartorius B, Fastner C, El-Battrawy I, Borggrefe M, Haubenreisser H, Meyer M, Schoenberg SO, Henzler T. --LAA Occluder View for post-implantation Evaluation (LOVE)--standardized imaging proposal evaluating implanted left atrial appendage occlusion devices by cardiac computed tomography. BMC Med Imaging. 2016 Mar 24;16:25. doi: 10.1186/s12880-016-0127-y. — View Citation

Fastner C, Behnes M, Sartorius B, Yildiz M, Mashayekhi K, El-Battrawy I, Lehmann R, Baumann S, Becher T, Borggrefe M, Akin I. Left atrial appendage morphology, echocardiographic characterization, procedural data and in-hospital outcome of patients receivi — View Citation

Outcome

Type	Measure	Description	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