Esophageal Injury of a Tip CF Sensing Ablation Catheter for HP-SD of Paroxysmal and Persistent AF (ESO-SAFE-HP-RF)

This pilot, prospective, interventional, monocentric, independent, and no-profit clinical trial aims to investigate and evaluate the proportion, acute and chronic characteristics, and outcomes of esophageal thermal injury (ETI) in AF ablation using a high-power, short-duration (HP-SD) setting with contact force (CF) sensing tip ablation catheter in standard clinical practice. The main questions it aims to answer are:Evaluate the acute proportion of the ETI assessed by the mini-invasive esophagoscopy pre and post-procedure. In addition, clinical evaluations at 3, 6, and 12 months from the procedure are foreseen.Evaluate the contribution of the factors influencing RF procedure (contact force, impedance, RF power, RF time) on ETI development.Describe the relationship between the esophageal temperature (continuous monitoring) and ETI development.

Inclusion Criteria:Atrial fibrillation and, according to current guidelines, indication for radiofrequency ablation guided by electro-anatomical mapping with high-density mapping catheter and radiofrequency ablation by contact force ablation catheter.Able to sign the consent form.Exclusion Criteria:LVEF < 45%Presence of thrombus in the left atriumNYHA III/IV ClassAtrial diameter > 50mmModerate or severe valve dysfunctionImplanted ICD/CRT-DLife expectancy < 1 yearUncontrolled HyperthyroidismHypertrophic or dilatative cardiomyopathyKidney failure (eGFR < 30)Body Mass Index (BMI)> or = 35Participation in another clinical trial in the past 3 monthsInability to express informed consent for the studyPatients with esophageal pathologies and a history of gastritisPregnancy (ascertained by performing the HCG test), breastfeeding, pregnancy planned during the study, or fertile female subjects who refused to use a highly effective contraceptive measure.