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

NCT02306460 | Terminated

• 1 other identifier: R14068
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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

Keywords

Neurobehavioral Manifestations; POCD; Atrial Fibrillation; Anti-Arrhythmia; Atrial Appendage Closure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in amplitude of N2/P3 complex in the EEG recording

  1 day before procedure, 3 months and 1 year after post-procedure

Study Arms (4)

left atrial catheter ablation

left atrial appendix closure

paroxysmal atrial fibrillation control group

persistent atrial fibrillation control group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tampere University Hospital: lead

Study Sites (1)

Tampere University Heart Hospital

Tampere, 33521, Finland

Location

MeSH Terms

Conditions

Neurobehavioral Manifestations; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes

Study Officials

• Kaisa Hartikainen, MD, Docent

  Behavioral Neurology Research Unit

  STUDY DIRECTOR

• Kati Järvelä, MD, PhD

  Tampere Heart Hospital

  STUDY DIRECTOR

• Arvi Yli-Hankala, MD, Professor

  Tampere University Hospital

  STUDY DIRECTOR

• Jonne Liimatainen, MD

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

• Pekka Raatikainen, MD, Docent

  Tampere Heart Hospital

  STUDY DIRECTOR

• Jaakko Inkovaara, MD

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 11, 2014
• First Posted: December 3, 2014
• Study Start: February 9, 2015
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 10, 2024

Record last verified: 2024-04

Locations

FI (1)