Clinical trial NCT02306460: Frontal Cognitive Control Functions Before and After Percutaneous Catheter Procedures in Treatment of Atrial Fibrillation
Official title: Frontal Cognitive Control Functions Before and After Percutaneous Catheter Procedures in Treatment of Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Neurobehavioral Manifestations
Atrial Fibrillation
Keywords: Neurobehavioral Manifestations
POCD
Atrial Fibrillation
Anti-Arrhythmia
Atrial Appendage Closure
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2014-12-03
Enrollment: 17
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Changes in response speeds (ms) and response error rate (%) in the executive RT-test
timeFrame: 1 day before procedure, 3 months and 1 year after post-procedure
Secondary outcomes:
measure: Changes in amplitude of N2/P3 complex in the EEG recording
timeFrame: 1 day before procedure, 3 months and 1 year after post-procedure
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Heart Hospital
Study officials:
affiliation: Behavioral Neurology Research Unit
name: Kaisa Hartikainen, MD, Docent
role: STUDY_DIRECTOR
affiliation: Tampere Heart Hospital
name: Kati Järvelä, MD, PhD
role: STUDY_DIRECTOR
affiliation: Tampere University Hospital
name: Arvi Yli-Hankala, MD, Professor
role: STUDY_DIRECTOR
affiliation: Tampere University Hospital
name: Jonne Liimatainen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tampere Heart Hospital
name: Pekka Raatikainen, MD, Docent
role: STUDY_DIRECTOR
affiliation: Tampere University Hospital
name: Jaakko Inkovaara, MD
role: PRINCIPAL_INVESTIGATOR
References: