Cerebral Embolism (CE) in Catheter Ablation of Atrial Fibrillation (AF)

Study Overview
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Brief Summary
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Radiofrequency catheter ablation of atrial fibrillation (AF) induces a procoagulant state, which leads to an acute risk for symptomatic cerebral embolism (CE) of approximately 1%. The induction of a procoagulant state has been studied in pulmonary vein isolation (PVI) with a non-cooled tip catheter. The induction of a procoagulant state using a cooled-tip catheter has not been studied yet. Due to the avoidance of high endocardial temperatures, it can be expected that these procedures induce a lower level of procoagulation. Recent studies showed an 11% incidence of CE on diffusion weighted (DW) MRI in patients undergoing cooled-tip catheter ablation of AF. In this study there will be used to different catheters, the cooled-tip catheter and the PVAC Gold catheter. Since the PVAC Gold catheter is equipped with non-cooled electrodes, the risk of endothelial scarring, local thrombosis and CE may be increased. The goal of this study is to determine the effect of two different ablation catheters on the induction of a procoagulant state and the incidence of CE on DW-MRI in patients with AF undergoing PVI. Our hypothesis is that patients with AF undergoing PVI using the PVAC gold catheter will show a higher rise in procoagulation and a higher incidence of CE on DW-MRI than patients with AF undergoing PVI with the cooled-tip catheter.

Detailed Description
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A total of 70 patients scheduled for a first ablation of paroxysmal AF will be included. Patients will be 1:1 randomized to PVI using the PVAC gold catheter or the cooled-tip catheter. A control group of 20 patients with AF but without undergoing ablation is included for neuropsychological testing. Before the procedure, the procoagulant state will be assessed by measuring several markers of endothelial damage, activated coagulation, fibrinolysis and by measurement of fibrinogen and thrombin generation. Measurements will be repeated during and after the procedure. Documentation of the formation of CE will be established by performing a DW-MRI before and after the ablation. The proportion of symptomatic CE will be quantified by neuropsychological tests and questionnaires. Finally, transcranial doppler will be performed during the entire procedure to quantify the number and pattern of cerebral microembolic signals (MES).

Official Title
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The Occurrence of Cerebral Embolism (CE) in Catheter Ablation of Atrial Fibrillation (AF) Using Two Different Ablation Catheters

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: PVI with PVAC gold
* Procedure: PVI with Cooled-RF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: suffering from drug-refractory paroxysmal atrial fibrillation scheduled for first ablation procedure Exclusion Criteria: contra-indications for DW-MRI previous AF-ablation minors any patient unable to undergo neuropsychological testing due to mental retardation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PVI with PVAC gold<br>Patient for pulmonal vein isolation using the PVAC Gold Catheter. Intervention. | Procedure: PVI with Cooled-RF<br>* Pulmonary vein isolation using the Biosense Webster Navistar Thermocool catheter<br>* Other names: CARTO3 system;|
| Active Comparator: PVI with Cooled-RF<br>Patient for pulmonal vein isolation using the Cooled-RF catheter. | Procedure: PVI with PVAC gold<br>* Pulmonary vein isolation using the Medtronic PVAC gold catheter<br>* Other names: Medtronic AF solutions;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral embolism | Cerebral embolism will be documented with diffusion weighted MRI of the brain before and after ablation. | Between 24 hours before the ablation and 24 hours after the ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychological functioning | A decrease in neuropsychological functioning will be assessed with a questionnaire before and after the procedure | Between a week before the ablation until 3 months after the ablation | 
| Rise in procoagulation | The procoagulant state will be assessed before, during and after the procedure by measurement of markers of endothelial damage, markers of activated coagulation, markers of fibrinolysis and by measurement of APTT, PT-INR, fibrinogen and thrombin generation. | Between 24 hours before the ablation and 24 hours after the ablation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, cerebral embolism, catheter ablation