RecruitingNot ApplicableNCT05758805

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

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

Sponsor

Quovadis Associazione

Enrollment

51 participants

Start Date

Jan 8, 2024

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation Esophageal Perforation Esophageal Fistula

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether a particular type of heart ablation catheter (used to treat irregular heart rhythms) causes less injury to the esophagus — the tube running behind the heart — compared to standard catheters. Ablation uses heat to correct abnormal electrical pathways causing atrial fibrillation. **You may be eligible if...** - You have atrial fibrillation (an irregular heartbeat) - Your doctor has recommended a catheter ablation procedure using a radiofrequency catheter with contact-force sensing technology - You are able to sign the consent form **You may NOT be eligible if...** - Your heart's pumping function is significantly reduced (ejection fraction below 45%) - You have a blood clot in the left side of your heart - You have severe heart failure (NYHA class III or IV) - Your heart is greatly enlarged (atrial diameter over 50mm) - You have moderate or severe heart valve problems, a pacemaker or defibrillator, severe kidney failure, uncontrolled thyroid problems, or a life expectancy under 1 year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEmini-invasive esophagoscopy

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

DEVICEHP-SD AF ablation by a CF sensing catheter

AF ablation session in an HP-SD setting and with a tip CF sensing ablation catheter