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"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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Biomarker levels before successful LAA occlusion device implantation | 24 hours before intervention |
| Measure | Description | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Ibrahim Akin, Prof. | University Medical Center Mannheim | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Centre Mannheim | Mannheim | Baden-Wurttemberg | 68167 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27009279 | Background | 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. | |
| 26822890 |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D001281 | Atrial Fibrillation |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
| mid-term follow up at 6 months |
| Result |
| 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 receiving left atrial appendage occlusion device implantation: a prospective observational study. BMC Cardiovasc Disord. 2016 Jan 28;16:25. doi: 10.1186/s12872-016-0200-z. |
| 29861102 | Derived | Rusnak J, Behnes M, Saleh A, Fastner C, Sattler K, Barth C, Wenke A, Sartorius B, Mashayekhi K, Hoffmann U, Yuecel G, Lang S, Borggrefe M, Akin I. Interventional left atrial appendage closure may affect metabolism of essential amino acids and bioenergetic efficacy. Int J Cardiol. 2018 Oct 1;268:125-131. doi: 10.1016/j.ijcard.2018.05.031. Epub 2018 Jun 1. |
| 29414920 | Derived | Fastner C, Behnes M, Sartorius B, Wenke A, Lang S, Yucel G, Sattler K, Rusnak J, Saleh A, Barth C, Mashayekhi K, Hoffmann U, Borggrefe M, Akin I. Interventional Left Atrial Appendage Closure Affects the Metabolism of Acylcarnitines. Int J Mol Sci. 2018 Feb 7;19(2):500. doi: 10.3390/ijms19020500. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |