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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02306460
• Other study ID #: R14068
• Status: Terminated
• Start date: February 9, 2015
• Est. completion date: December 2020

Study information

• Verified date: April 2024
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Neurobehavioral Manifestations

Locations

Country	Name	City	State
Finland	Tampere University Heart Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in amplitude of N2/P3 complex in the EEG recording		1 day before procedure, 3 months and 1 year after post-procedure