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

Sponsor

Quovadis Associazione (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05758805

Collaborator

Abbott (Industry)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Esophageal Perforation Esophageal Fistula	Device: mini-invasive esophagoscopy Device: HP-SD AF ablation by a CF sensing catheter	N/A

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:

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

51 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Pilot, about the safety, prospective, monocentricPilot, about the safety, prospective, monocentric

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Oct 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Unique Arm 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 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

Arm

Intervention/Treatment

Experimental: Unique Arm

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

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

Outcome Measures

Primary Outcome Measures

Proportion of the acute esophageal thermal injury (ETI) [1-3 days after AF ablation procedure]
Evaluate the acute proportion of the esophageal thermal injury (ETI)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.