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

Terminated

• Conditions: Neurobehavioral Manifestations; Atrial Fibrillation

• Registration Number: NCT02306460
• Lead Sponsor: Tampere University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-11
• Study First Submitted QC: 2014-11-30
• Study First Posted: 2014-12-03
• Study Start: 2015-02-09
• Primary Completion: 2020-12
• Study Completion: 2020-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Changes in amplitude of N2/P3 complex in the EEG recording	1 day before procedure, 3 months and 1 year after post-procedure

Trial Locations

Locations (1)

Tampere University Heart Hospital; 🇫🇮 Tampere, Finland