Esophageal Injury of a Tip CF Sensing Ablation Catheter for HP-SD of

Status Recruiting

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05758805
Study type	Interventional
Source	Quovadis Associazione
Contact	Antonio Dello Russo, MD
Phone	+39 ?0715965798?
Email	antonio.dellorusso@ospedaliriuniti.marche.it
Status	Recruiting
Phase	N/A
Start date	January 8, 2024
Completion date	October 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms