Left Atrial Appendage Occlusion and Biomarker Evaluation

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02985463

Acronym

LABEL

Enrollment

Registered

2016-12-07

Start date

2014-06-30

Completion date

2021-12-31

Last updated

2020-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Bleeding, Stroke

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Biomarker levels before successful LAA occlusion device implantation	24 hours before intervention

Secondary

Measure	Time frame
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

Countries

Germany

Outcome results