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

Study Overview
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Brief Summary
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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.

Detailed Description
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This study aims to estimate the proportion of esophageal thermal injury (ETI) as a result of the AF ablation using a high-power, short-duration (HP-SD) setting with contact force (CF) sensing tip ablation catheter immediately after and at 3, 6, and 12 months from the procedure, as well as describe their characteristics. To be more sensitive and specific in detecting the presence of potentially chronic and progressing ETIs in esophageal ulcers and atrium-esophageal fistula, a minimally invasive esophagogastroscope will be used before (1-7 days) and after (1-3 days) the ablation procedure, with an internal comparison of the lesions observed. In addition, various clinical characteristics of the patients and descriptors of the ablation procedure (such as contact force, impedance, RF power, RF time, esophageal temperature, procedure times, etc.) will be collected and related to the presence of ETI. The principal Medical Devices that will be used: Cardiac Mapping system Ensite X (Abbott Medical), Tip CF sensing catheter TactiFlex (Abbott Medical), High mapping density catheter (HD GRID/Advisor FL, Abbott Medical), Continuous temperature monitoring devices (Esotest Multi/Esotherm 7 poles, FIAB), Video-endoscope EXERA III HDTV dual focus GIF-HQ190 (Olympus).

Official Title
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Esophageal Injury of a Tip CF Sensing Ablation Catheter for HP-SD of Paroxysmal and Persistent AF

Conditions
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Atrial Fibrillation, Esophageal Perforation, Esophageal Fistula

Intervention / Treatment
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* Device: mini-invasive esophagoscopy
* Device: HP-SD AF ablation by a CF sensing catheter


Participation Criteria
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Eligibility Criteria
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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 atrium NYHA III/IV Class Atrial diameter > 50mm Moderate or severe valve dysfunction Implanted ICD/CRT-D Life expectancy < 1 year Uncontrolled Hyperthyroidism Hypertrophic or dilatative cardiomyopathy Kidney failure (eGFR < 30) Body Mass Index (BMI)> or = 35 Participation in another clinical trial in the past 3 months Inability to express informed consent for the study Patients with esophageal pathologies and a history of gastritis 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Pilot, about the safety, prospective, monocentric
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unique Arm<br>patients with atrial fibrillation and indication for radiofrequency ablation guided by electro-anatomical mapping with high-density mapping catheter and radiofrequency ablation by contact force ablation catheter, according to current guidelines | Device: mini-invasive esophagoscopy<br>* mini-invasive esophagoscopy assessment of esophageal thermal injury (ETI) after an AF ablation session in an HP-SD setting, and with a tip CF sensing ablation catheter<br>Device: HP-SD AF ablation by a CF sensing catheter<br>* AF ablation session in an HP-SD setting and with a tip CF sensing ablation catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of the acute esophageal thermal injury (ETI) | Evaluate the acute proportion of the esophageal thermal injury (ETI) | 1-3 days after AF ablation procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors influencing RF procedure on ETI development | Contribution of the factors influencing RF procedure (contact force, impedance, RF power, RF time) on ETI development | 1-3 days after AF ablation procedure | 
| Esophageal temperature by an esophageal continuous monitoring device | Celsius degree. | during AF ablation procedure | 
| ETI monitoring | Chronic (every 3 months until healing) evaluation of discovered ETI. | 12 months after AF ablation procedure | 
| AF ablation procedure times | minutes | 1 day | 
| AF recurrences | AF recurrences until 12 months after the ablation procedure | 12 months after AF ablation procedure | 
| Serious and no serious adverse events | Serious and no serious adverse events after the ablation procedure | 12 months after AF ablation procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esophageal thermal injury (ETI), AF ablation, high-power, short-duration (HP-SD), mini-invasive esophagoscopy