Left Atrial Appendage Occlusion and Biomarker Evaluation
NCT ID: NCT02985463
Last Updated: 2020-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2014-06-30
2021-12-31
Brief Summary
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Detailed Description
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Biomarker evaluation will focus on blood derived biomarkers including neurohormones, proteins, cytokines, microRNAs and metabolomics.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* contraindication for the therapy with oral anticoagulants:
* refusal to take oral anticoagulation
* HasBled-score more than 3
* prior bleedings under oral anticoagulation
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Universitätsmedizin Mannheim
OTHER
Responsible Party
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Michael Behnes
Dr. med
Principal Investigators
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Ibrahim Akin, Prof.
Role: STUDY_DIRECTOR
University Medical Center Mannheim
Locations
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University Medical Centre Mannheim
Mannheim, Baden-Wurttemberg, Germany
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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2014-402M-MA-§ 23b MPG
Identifier Type: -
Identifier Source: org_study_id
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