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)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Esophageal Perforation; Esophageal Fistula
• Intervention / Treatment: Device: mini-invasive esophagoscopy; Device: HP-SD AF ablation by a CF sensing catheter

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).

• Study Type: Interventional
• Enrollment (Estimated): 51
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antonio Dello Russo, MD; Phone Number: +39 ‭0715965798‬; Email: antonio.dellorusso@ospedaliriuniti.marche.it
• Study Contact Backup: Name: Franco Noventa, MD; Phone Number: +39 049715373; Email: franco.noventa@quovadis-ass.it

Study Locations

• Italy
  • Ancona, Italy, 60126
    • Recruiting
    • SOD di Cardiologia e Aritmologia
    • Contact: Antonio Dello Russo, MD; Phone Number: 071 5965799; Email: antonio.dellorusso@ospedaliriuniti.marche.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. Able to sign the consent form.

Exclusion Criteria:

1. LVEF < 45%
2. Presence of thrombus in the left atrium
3. NYHA III/IV Class
4. Atrial diameter > 50mm
5. Moderate or severe valve dysfunction
6. Implanted ICD/CRT-D
7. Life expectancy < 1 year
8. Uncontrolled Hyperthyroidism
9. Hypertrophic or dilatative cardiomyopathy
10. Kidney failure (eGFR < 30)
11. Body Mass Index (BMI)> or = 35
12. Participation in another clinical trial in the past 3 months
13. Inability to express informed consent for the study
14. Patients with esophageal pathologies and a history of gastritis
15. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Quovadis Associazione
• Collaborators: Abbott
• Investigators: Principal Investigator: Antonio Dello Russo, MD, Cardiology and Arrhythmology Dept., Azienda Ospedaliero Universitaria delle Marche, Ancona (Italy)

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 7, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: AF ablation; esophageal thermal injury (ETI); high-power, short-duration (HP-SD); mini-invasive esophagoscopy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Wounds and Injuries; Gastrointestinal Diseases; Pathological Conditions, Anatomical; Arrhythmias, Cardiac; Esophageal Diseases; Digestive System Fistula; Atrial Fibrillation; Fistula; Esophageal Perforation; Esophageal Fistula
• Other Study ID Numbers: ESO-SAFE-HP-RF Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no IPD share planned

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No