NCT02306460|Terminated
Study Stopped
Changes in personnel
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Changes in personnel
Sponsor study identifier
observational
17
1 country
1
Study Start
February 9, 2015
Actual (reported)Primary Completion
December 2020
Actual (reported)Study Completion
December 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 11, 2014
Actual (reported)December 3, 2014
Actual (reported)February 9, 2015
Actual (reported)December 2020
Actual (reported)December 2020
Actual (reported)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
Changes in amplitude of N2/P3 complex in the EEG recording
1 day before procedure, 3 months and 1 year after post-procedure
A total of 80 patients will be drafted for the study. The subjects will be recruited from Tampere University Hospital Heart Hospital Co. Total of fifty patients, men and women between 50-70 years, undergoing left atrial catheter ablation (LACA) (30 patients) or percutaneous left atrial appendix closure procedure (20 patients) because of paroxysmal or persistent atrial fibrillation, will be recruited for the study. A control group of 15 patients with paroxysmal atrial fibrillation and 15 patients with persistent atrial fibrillation who are treated with antiarrhythmic and anticoagulation therapies suggested by current guidelines will be tested with the same testing schema and time points. Control group will be drafted from the cardiologic patients of the Heart Hospital and also from Hatanpää Hospital cardiologic outpatient clinic.
Tampere University Heart Hospital
Tampere, 33521, Finland
Kaisa Hartikainen, MD, Docent
Behavioral Neurology Research Unit
Kati Järvelä, MD, PhD
Tampere Heart Hospital
Arvi Yli-Hankala, MD, Professor
Tampere University Hospital
Jonne Liimatainen, MD
Tampere University Hospital
17 participants (actual enrollment reported by the registry).
First Submitted
July 11, 2014
First Posted
December 3, 2014
Study Start
February 9, 2015
Actual (reported)Hybrid Atrial Fibrillation Ablation Registry
Contact the study team to confirm eligibility.
Pekka Raatikainen, MD, Docent
Tampere Heart Hospital
Jaakko Inkovaara, MD
Tampere University Hospital
Primary Completion
December 2020
Actual (reported)Study Completion
December 2020
Actual (reported)Last Updated
April 10, 2024
Record last verified: 2024-04
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Source: ClinicalTrials.gov.
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