Clinical trial NCT02985463: Left Atrial Appendage Occlusion and Biomarker Evaluation
Official title: Left Atrial Appendage Occlusion and Biomarker Evaluation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Atrial Fibrillation
Bleeding
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2016-12-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Biomarker levels before successful LAA occlusion device implantation
timeFrame: 24 hours before intervention
Secondary outcomes:
measure: Biomarker levels after successful LAA occlusion device implantation
timeFrame: mid-term follow up at 6 months
measure: 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)
timeFrame: mid-term follow up at 6 months
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: University Medical Centre Mannheim
state: Baden-Württemberg
Study officials:
affiliation: University Medical Center Mannheim
name: Ibrahim Akin, Prof.
role: STUDY_DIRECTOR
References:
citation: 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.
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 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.
citation: 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.
citation: 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.