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

NCT ID: NCT05758805

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-08
• Study Completion Date: 2025-10-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

mini-invasive esophagoscopy

Intervention Type: 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

HP-SD AF ablation by a CF sensing catheter

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: collaborator

Quovadis Associazione

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio Dello Russo, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

SOD di Cardiologia e Aritmologia

Ancona, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Antonio Dello Russo, MD

Role: CONTACT

antonio.dellorusso@ospedaliriuniti.marche.it

+39 ‭0715965798‬

Franco Noventa, MD

Role: CONTACT

franco.noventa@quovadis-ass.it

+39 049715373

Facility Contacts

Antonio Dello Russo, MD

Role: primary

antonio.dellorusso@ospedaliriuniti.marche.it

071 5965799

Other Identifiers

ESO-SAFE-HP-RF Study

Identifier Type: -

Identifier Source: org_study_id