Clinical and Electrophysiological Predictors of Arrhythmic Recurrence in Patients With Paroxysmal AF Undergoing First Ablation Procedure of AF by Pulmonary Vein Isolation

Study Overview
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Brief Summary
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From the literature, the success rate (i.e., absence of AF recurrence) of ablation in cases of paroxysmal AF at one year changes between 70 and 85 percent. This rate is considered suboptimal. Currently there are no data that can assess which factors are predictive of recurrence both clinically and electrophysiologically. In particular, it is not known whether and to what extent the atrial substrate present under baseline conditions affects the success rate of the procedure and what relationships exist with other predictors such as age, sex, atrial size at echo, and duration of arrhythmia.

Detailed Description
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This is a multicenter prospective and retrospective observational study aimed at examining the role of the left atrial substrate and other baseline clinical variables on the efficacy of transcatheter ablation in patients with paroxysmal atrial fibrillation (AF) who underwent pulmonary vein isolation regardless of the power source and balloon or point by point catheters used. The study will evaluate whether there are baseline clinical or electrophysiological features that can predict the success of transcatheter atrial fibrillation ablation even before it is performed, so as to assess which patients may actually benefit, and which patients should instead undergo more extensive ablative procedures in conjunction with pulmonary vein isolation to achieve an optimal success rate.

Official Title
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Clinical and Electrophysiological Predictors of Arrhythmic Recurrence in Patients With Paroxysmal Atrial Fibrillation Undergoing First Transcatheter Ablation Procedure of Atrial Fibrillation by Pulmonary Vein Isolation

Conditions
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Atrial Fibrillation Paroxysmal

Intervention / Treatment
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* Other: Standard of care
* Other: Data collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with indication for AF ablation Adequate anticoagulation therapy according to CHADs VASC Exclusion Criteria: patients who had already undergo an AF ablation procedure Presence of intracavitary thrombus Ejection fraction <35% Pregnancy Hematologic contraindications to ionizing radiation exposure Congenital heart diseases Cardiac Surgery < 1month Uncontrolled heart failure Valvular disease Contraindications to general anesthesia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective cohort<br>Patients with paroxysmal AF with clinical indication to first transcatheter ablation procedure of AF by pulmonary vein isolation | Other: Standard of care<br>* All patients will undergo, as clinically indicated, AF ablation by pulmonary vein isolation achievable by radiofrequency, cryoenergy, or electroporation. All patients will preliminarily undergo electroanatomic mapping of the atrium by CARTO/Navx/Rhythmia system indifferently. Patients will be given follow-up visits at 3-6-12 months, during which any arrhythmic recurrences will be assessed<br>|
| Retrospective cohort<br>Patients who underwent ablative procedure in the two years prior to the start of the study | Other: Data collection<br>* There's no patient involvement. Data of patients who underwent ablative procedures two years before the start of the study will be retrospectively analyzed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess clinical and electrophysiological predictors of arrhythmic recurrence | Evaluate the role of atrial disease, assessed by baseline electroanatomic mapping, age, gender, echocardiographic data, years from first AF episode, in predicting AF recurrence after AF ablation. | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate acute and mid- to long-term efficacy, safety, and procedural timing of different technologies | Evaluate mid and long term efficacy, safety, procedural timing between Cryo ablation, Pulsed Field Ablation, Radio Frequency ablation, point by point or single shot ablation of paroxysmal atrial fibrillation. | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary vein isolation, atrial fibrillation, catheter ablation, electroanatomical map