NCT05758805

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: Quovadis Associazione · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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: 1. Cardiac Mapping system Ensite X (Abbott Medical), 2. Tip CF sensing catheter TactiFlex (Abbott Medical), 3. High mapping density catheter (HD GRID/Advisor FL, Abbott Medical), 4. Continuous temperature monitoring devices (Esotest Multi/Esotherm 7 poles, FIAB), 5. Video-endoscope EXERA III HDTV dual focus GIF-HQ190 (Olympus).

Conditions

• Atrial Fibrillation
• Esophageal Perforation
• Esophageal Fistula

Interventions

Type	Name	Description
DEVICE	mini-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
DEVICE	HP-SD AF ablation by a CF sensing catheter	AF ablation session in an HP-SD setting and with a tip CF sensing ablation catheter

Timeline

• Start date: 2024-01-08
• Primary completion: 2025-07-01
• Completion: 2025-10-01
• First posted: 2023-03-07
• Last updated: 2024-05-09

Locations

1 site across 1 country: Italy