Frontal Cognitive Control Functions Before and After Percutaneous Catheter Procedures in Treatment of Atrial Fibrillation

Study Overview
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Brief Summary
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Atrial fibrillation is a common arrythmia. It is an independent risk factor for stroke. There for anticoagulation therapy is used for atrial fibrillation patients. Alternatively, left atrial appendix closure can be used, if the risk for bleeding complications is deemed greater than the possible antithrombotic benefit of anticoagulation medication. Up to 70% of ischemic complications can be prevented with anticoagulation therapy, and left atrial appendix closure seems to have comparable results. Also left atrial catherter ablation (LACA) is gaining popularity as a therapeutic intervention for atrial fibrillation. However, the procedure is associated with 0,5-1% perioperative risk of clinically evident transient ischemic attack (TIA) or stroke. While the incidence of clinically evident ischemic complications remain relatively low, recent data suggest that 13%-20% of patients undergoing LACA are affected by post-operative neurocognitive dysfunction (POCD) 90 days after ablation. The goal of the study is to improve detection of subtle brain dysfunction after cardiac interventions by employing an experimental executive reaction time (RT) test along with EEG recording in aims to improve objective detection of subtle brain dysfunction assumed to underlie persistent cognitive, somatic, and affective complaints reported by patients who have undergone atrial fibrillation ablation.

Official Title
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Frontal Cognitive Control Functions Before and After Percutaneous Catheter Procedures in Treatment of Atrial Fibrillation

Conditions
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Neurobehavioral Manifestations, Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 50-70 undergoing left atrial catheter ablation or percutaneous left atrial appendix closure procedure In the ablation group, patients will qualify for the study if they have symptomatic atrial fibrillation (EHRA classification 2-4) and if their risk of thromboembolic complications with CHA2DS2VASc scale is low (0-2 points). Exclusion Criteria: Age under 18 or over 70 years. Contraindication for anticoagulation therapy (in ablation group), Previous neurological or psychiatric disorder. Significant visual problem that can't be corrected for, problems with upper arm/hand use, that would make the execution of the test difficult. normal contraindications for the ablation and appendix closure procedures.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| left atrial catheter ablation<br> | |
| left atrial appendix closure<br> | |
| paroxysmal atrial fibrillation control group<br> | |
| persistent atrial fibrillation control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in response speeds (ms) and response error rate (%) in the executive RT-test |  | 1 day before procedure, 3 months and 1 year after post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in amplitude of N2/P3 complex in the EEG recording |  | 1 day before procedure, 3 months and 1 year after post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurobehavioral Manifestations, POCD, Atrial Fibrillation, Anti-Arrhythmia, Atrial Appendage Closure