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

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.

Study Overview

• Status: Terminated
• Conditions: Neurobehavioral Manifestations; Atrial Fibrillation

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland, 33521
    • Tampere University Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
left atrial catheter ablation
left atrial appendix closure
paroxysmal atrial fibrillation control group
persistent atrial fibrillation control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Investigators: Study Director: Kaisa Hartikainen, MD, Docent, Behavioral Neurology Research Unit; Study Director: Kati Järvelä, MD, PhD, Tampere University Heart Hospital; Study Director: Arvi Yli-Hankala, MD, Professor, Tampere University Hospital; Principal Investigator: Jonne Liimatainen, MD, Tampere University Hospital; Study Director: Pekka Raatikainen, MD, Docent, Tampere University Heart Hospital; Principal Investigator: Jaakko Inkovaara, MD, Tampere University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2015
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: July 11, 2014
• First Submitted That Met QC Criteria: November 30, 2014
• First Posted (Estimated): December 3, 2014

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Neurobehavioral Manifestations; POCD; Anti-Arrhythmia; Atrial Appendage Closure
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Arrhythmias, Cardiac; Atrial Fibrillation; Neurobehavioral Manifestations
• Other Study ID Numbers: R14068