Pulmonary Veins Circular Ablation Catheter Evaluation for Atrial Fibrillation

Study Overview
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Brief Summary
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The aim of this study is to compare two type of ablation catheters for pulmonary veins isolation (PVI) in subjects with atrial fibrillation. Currently, two technologies of irrigated ablation catheters are available for PVI. One of the two, the conventional catheter is widely used for atrial fibrillation (AF) treatment but has not been specifically created for pulmonary veins isolation, therefore, point by point encircling lesions are cumbersome and time consuming. The second is a new ablation catheter with a circular shape provided with 10 irrigated electrodes designed to create encircling lesions, necessary to obtain pulmonary veins isolation, could allow an easier and faster isolation compared to the conventional way. These two types of catheters have never been compared for atrial fibrillation. If one of the two catheters appears to be more efficient or causes fewer complications, the use of this catheter could be favored to conduct AF ablation.

Official Title
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Pulmonary Veins Circular Ablation Catheter Evaluation for Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: nMARQ catheter
* Device: Navistar catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject with atrial fibrillation refractory to anti-arrhythmic drugs, with episodes lasting less than 7 days and eligible for atrial fibrillation ablation. Age superior or equal to 18 years old, both genders. Patient's oral agreement for study participation after reading information note. Patient affiliated or recipient of a social welfare regimen. Exclusion Criteria: Age inferior to 18 years old Pregnancy Unbalanced psychiatric disorders Contraindication to atrial fibrillation ablation by endocardial way. Redo-ablation No patient's oral agreement for study participation

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: nMARQ catheter (circular catheter)<br>Group treated with the circular ablation catheter for atrial fibrillation ablation | Device: nMARQ catheter<br>* In this arm the circular ablation catheter will be used for a quick mapping of left atrium with Carto system. The catheter will be positioned to pulmonary veins ostium to deliver radiofrequency on 1 to 10 electrodes simultaneous. The same catheter will be used to document pulmonary veins isolation (PVI). A waiting period of 30 minutes will be observed after PVI to document possible reconnection(s). Adenosine will be injected (except in case of adenosine contraindication) and reconnection(s) site(s) will be noted.<br>|
| Active Comparator: Navistar catheter (conventional catheter)<br>Group treated with the conventional ablation catheter for atrial fibrillation ablation | Device: Navistar catheter<br>* In this arm the conventional catheter will be used. It will be used for a left atrium quick mapping on Carto system. Radiofrequency will be delivered in a sequential manner in pulmonary veins for point by point ablation. Isolation will be guided and confirmed with the Lasso decapolar diagnostic catheter (Biosense Webster, Diamond Bar, USA). A waiting period of 30 minutes will be observed after PVI to document possible reconnection(s). Adenosine will be injected (except in case of adenosine contraindication) and reconnection(s) sites will be noted.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Pulmonary veins reconnection | Number of Pulmonary veins reconnection 30 minutes after the isolation in each group + ATP injection (number between 0 and 4) | End of ablation procedure |