Hybrid Characterization of Driver Sites During Atrial Fibrillation and Sinus Rhythm

Study Overview
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Brief Summary
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The primary objective of this study is twofold, first we aim to identify rotors in atrial fibrillation (AF) and analyze their relationship with the left atrium-left atrial appendage (LA-LAA) connections. Secondly, we will analyze the areas harboring rotors in SR to define the characteristics that describe the presence of rotors.

Detailed Description
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The primary objective of this study is the identification of LA and LAA areas driving atrial fibrillation to study their relationship with LAA-LA connections and sinus rhythm (SR) analysis using the CartoFinder and COHERENT algorithms that CARTO V7 offers. The CartoFinder tool will be able to determine the activation patterns of reentrant drivers (rotors) in the LA and LAA in AF. The characterization of areas harboring rotors could be performed with the COHERENT tool provided by CARTO V7 to determine the activation patterns during reentrant rhythms, and after sinus rhythm restoration it could be used to assess the conduction patterns at LA-LAA connections and driver sites identified with CartoFinder.

Official Title
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Hybrid Characterization of Driver Sites During Atrial Fibrillation and Sinus Rhythm With CARTOFINDER and COHERENT Mapping

Conditions
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Persistent Atrial Fibrillation

Intervention / Treatment
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* Procedure: Pulmonary vein electrical isolation
* Device: Atrial substrate mapping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persistent atrial fibrillation The patient has signed the informed consent form No LAA previous ablation procedure No valvular disease LVEF ≥ 35% prior to recruitment Age ≥ 18 years Exclusion Criteria: LVEF < 35 % Hyperthyroidism or hypothyroidism Mental or physical illness incapacitation Planned cardiac procedure Non-controlled hypertension Terminal renal failure or dialysis Class IV of the NYHA Age ≥ 75 years Life expectancy < 2 years Atrioventricular block Pregnancy

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

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>LAA + LA Map in AF Identify LAA connections and detect rotors with CartoFinder Electrical cardioversion. Sinus rhythm restoration Pacing from the coronary sinus at 300 and 600ms periods Analyze COHERENT activation maps in sinus rhythm Ablation as suggested by current clinical guidelines and the characteristics of the patient | Procedure: Pulmonary vein electrical isolation<br>* Electrical isolation of the pulmonary veins from the left atrium with cryoablation therapy.<br>* Other names: Pulmonary veins ablation;Device: Atrial substrate mapping<br>* Electro-anatomical maps will be performed with CARTO navigation system with multi-electrode catheters.<br>* Other names: Electro-anatomical mapping;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CartoFinder and COHERENT tools utility assessment | To evaluate the utility of CartoFinder and COHERENT tools in the identification of the mechanisms that maintain atrial fibrillation. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation driver location analysis | Reentrant driver location relationship with lines of block, wavefront curvature, and slow conduction areas during SR pacing with success AF termination. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Catheter ablation, Rotors