Noninvasive 3D Mapping in Persistent Atrial Fibrillation, to Describe Modifications of the Arrhythmogenic Substrate After Pulmonary Vein Isolation and Identify Potential Predicting Factors of Ablation Success

Study Overview
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Brief Summary
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Atrial fibrillation (AF) is the most common cardiac arrhythmia in adults. It is a major cause of ischemic stroke and heart failure. Intravascular cardiac ablation of the left atrium by catheter delivery is an efficient treatment to restore sinus rhythm. AF ablation is a class IIa treatment for patients with symptomatic persistent AF refractory or intolerant to antiarrhythmic medication. There are still many debates considering the ablation strategy. The pulmonary veins remain the cornerstone of AF ablation therapy, even in persistent AF. There is a large electrical remodeling occurring in the left atrium between paroxysmal AF, early persistent AF and long-standing persistent AF. However, no multicentric and randomized study has demonstrated so far the interest of targeting other left atrial substrate, such as rotors or focal sources. Our study aims to describe with a noninvasive mapping system the arrhythmogenic substrate of persistent AF > 6 months pre- and post-cardioversion, and after pulmonary vein isolation.

Official Title
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Noninvasive 3D Mapping in Persistent Atrial Fibrillation, to Describe Modifications of the Arrhythmogenic Substrate After Pulmonary Vein Isolation and Identify Potential Predicting Factors of Ablation Success

Conditions
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Atrial Fibrillation, Persistent

Intervention / Treatment
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* Device: Noninvasive mapping (Cardioinsight® system)
* Device: long-term cardiac monitoring (LINQ system)
* Procedure: Atrial Fibrillation ablation procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with documented persistent Atrial Fibrillation lasting longer than 6 months documented by 24h holter monitoring Age between 18 and 75 years Efficient oral anticoagulation during at least 1 month before the procedure Social security affiliation Feasible patient follow-up Patient willing to comply with study requirements and give informed consent to participate in this clinical study Indication for Pulmonary Vein isolation Exclusion Criteria: Previous atrial fibrillation ablation Previous left atrial ablation or surgery Atrial fibrillation without spontaneous RR interval > 1000ms and with LVEF < 35% (measured by TTE) Presence of a mechanical mitral valve Current intracardiac thrombus Any condition contraindicating chronic anticoagulation Uncontrolled hyperthyroidism Anteroposterior LA diameter > 55 mm measured by TTE Body mass index ≥ 40 kg/m2

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patient with persistent atrial fibrillation<br>persistent atrial fibrillation is defined as lasting longer than 6 months documented by a 24h holter monitoring | Device: Noninvasive mapping (Cardioinsight® system)<br>* Noninvasive mapping (Cardioinsight® system) of the left atria before the Atrial fibrilation ablation procedure<br>Device: long-term cardiac monitoring (LINQ system)<br>* long-term cardiac monitoring (LINQ system) is used to evaluate recurrence rate following AF ablation procedure<br>Procedure: Atrial Fibrillation ablation procedure<br>* Atrial Fibrillation ablation procedure is done with standard practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of focal sources and rotors in atrial segments |  | within 1 hour post-cardioversion procedure | 
| Number of focal sources and rotors in atrial segments |  | within 1 hour post-Pulmonary Vein Isolation procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Atrial Fibrillation recurrence following AF ablation procedure |  | 1 year post-procedure | 
| Number of success of Atrial Fibrillation induction after initial electrical cardioversion |  | within 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary vein isolation, cardioversion