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

NCT ID: NCT02306460

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 17 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-02-09
• Study Completion Date: 2020-12-31

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.

Conditions

Neurobehavioral Manifestations; Atrial Fibrillation

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

left atrial catheter ablation

No interventions assigned to this group

left atrial appendix closure

No interventions assigned to this group

paroxysmal atrial fibrillation control group

No interventions assigned to this group

persistent atrial fibrillation control group

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tampere University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kati Järvelä

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kaisa Hartikainen, MD, Docent

Role: STUDY_DIRECTOR

Behavioral Neurology Research Unit

Kati Järvelä, MD, PhD

Role: STUDY_DIRECTOR

Tampere Heart Hospital

Arvi Yli-Hankala, MD, Professor

Role: STUDY_DIRECTOR

Tampere University Hospital

Jonne Liimatainen, MD

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Pekka Raatikainen, MD, Docent

Role: STUDY_DIRECTOR

Tampere Heart Hospital

Jaakko Inkovaara, MD

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Locations

Tampere University Heart Hospital

Tampere, , Finland

Countries

Finland

Other Identifiers

R14068

Identifier Type: -

Identifier Source: org_study_id