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

NCT05758805 | Recruiting

• 1 other identifier: ESO-SAFE-HP-RF Study
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Esophageal Perforation; Esophageal Fistula

Keywords

esophageal thermal injury (ETI); AF ablation; high-power, short-duration (HP-SD); mini-invasive esophagoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Factors influencing RF procedure on ETI development

  1-3 days after AF ablation procedure

• Esophageal temperature by an esophageal continuous monitoring device

  during AF ablation procedure

• ETI monitoring

  12 months after AF ablation procedure

• AF ablation procedure times

  1 day

• AF recurrences

  12 months after AF ablation procedure

Study Arms (1)

Unique Arm

EXPERIMENTAL

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; Device: HP-SD AF ablation by a CF sensing catheter

Interventions

mini-invasive esophagoscopy DEVICE

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

Unique Arm

HP-SD AF ablation by a CF sensing catheter DEVICE

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

Unique Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Quovadis Associazione: lead
• Abbott: collaborator

Study Sites (1)

SOD di Cardiologia e Aritmologia

Ancona, 60126, Italy

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Esophageal Perforation; Esophageal Fistula

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Wounds and Injuries; Digestive System Fistula; Fistula; Pathological Conditions, Anatomical

Study Officials

• Antonio Dello Russo, MD

  Cardiology and Arrhythmology Dept., Azienda Ospedaliero Universitaria delle Marche, Ancona (Italy)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Dello Russo, MD

CONTACT

+39 ‭0715965798‬; antonio.dellorusso@ospedaliriuniti.marche.it

Franco Noventa, MD

CONTACT

+39 049715373; franco.noventa@quovadis-ass.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot, about the safety, prospective, monocentric

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 7, 2023
• Study Start: January 8, 2024
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)