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

Summary

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.

Eligibility

Inclusion Criteria:

1. 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.
2. Able to sign the consent form.

Exclusion Criteria:

1. LVEF \< 45%
2. Presence of thrombus in the left atrium
3. NYHA III/IV Class
4. Atrial diameter \> 50mm
5. Moderate or severe valve dysfunction
6. Implanted ICD/CRT-D
7. Life expectancy \< 1 year
8. Uncontrolled Hyperthyroidism
9. Hypertrophic or dilatative cardiomyopathy
10. Kidney failure (eGFR \< 30)
11. Body Mass Index (BMI)\> or = 35
12. Participation in another clinical trial in the past 3 months
13. Inability to express informed consent for the study
14. Patients with esophageal pathologies and a history of gastritis
15. Pregnancy (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.

Conditions4

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