Baroreflex Sensitivity in Patients Undergoing Ablation of Atrial Fibrillation

Study Overview
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Brief Summary
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Atrial fibrillation is the most common arrhythmia. The posterior surface of the left atrium is covered by an extensive network belonging to the autonomic nervous system that can be damaged during the ablation. The involvement of the autonomous nervous system in the genesis and maintenance of atrial fibrillation remains poorly understood. Baroreflex sensitivity is a non-invasive method assessing autonomous nervous system activity. The rate of atrial fibrillation recurrence after ablation is currently high and a better understanding of the mechanisms associated with recurrence is essential to improve selection of the patients who will benefit the most from this procedure. The aim of this study is to evaluate the association between the baroreflex sensitivity and atrial fibrillation recurrences and to analyze the prognostic contribution of the baroreflex measurement compared to other published criteria.

Official Title
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Baroreflex Sensitivity in Patients Undergoing Atrial Fibrillation Ablation: Association With Arrhythmia Recurrences

Conditions
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Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Procedure: pulmonary vein isolation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old, Patients with paroxysmal atrial fibrillation, hospitalized for atrial fibrillation ablation, Assessable baroreflex sensitivity before ablation, Free subject, without guardianship or curatorship or subordination, Patients benefiting from a Social Security assurance, Informed consent signed by the patient after clear and fair information about the study. Exclusion Criteria: Age < 18, History of atrial fibrillation ablation, Inability to calculate the baroreflex sensitivity Contraindication to the performance of a cardiac CT scan (allergy to iodine, severe renal insufficiency with clearance <30 ml/mn/m2), Inability to have continuous ECG recording by subcutaneous Holter,

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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

| Intervention/Treatment |
| --- |
|Procedure: pulmonary vein isolation|pulmonary vein isolation : cryoablation or radiofrequency|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean slope assessed before ablation in the recurrence and the non-recurrence groups | To compare baroreflex sensitivity assessed by mean Slope 1 month before the ablation in the recurrence group at 1 year and in the no AF recurrence group at 1 year. | Recurrence is assessed at one year of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between baroreflex sensitivity assessed before ablation and atrial fibrillation burden | Association between baroreflex sensitivity evaluated by mean slope, LF gain and HF gain 1 month before AF ablation and AF burden after 1 year of follow-up; | Burden is assessed at one year of follow-up | 
| Baroreflex sensitivity fall between the groups with and without AF recurrence | To compare the baroreflex sensitivity fall between before and day1 of ablation between the groups with and without AF recurrence at 1 year follow-up ; | Recurrence is assessed at one year of follow-up | 
| Evolution of baroreflex sensitivity | To describe the evolution of baroreflex sensitivity in the group with and in the group without recurrence. | Before, day 1 and month 3 after the ablation | 
| Biological and imaging parameters | To look for an association between biological and imaging parameters and atrial fibrillation burden at 1 year. | Burden is assessed at one year of follow-up | 
| Quality of life | To compare quality of life before and at one year after atrial fibrillation ablation in patients with and without AF recurrence; | before and at one year after atrial fibrillation ablation |