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

Atrial Fibrillation Clinical Trial

— ESO-SAFE-HP-RF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05758805
• Other study ID #: ESO-SAFE-HP-RF Study
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2024
• Est. completion date: October 2025

Study information

• Verified date: May 2024
• Source: Quovadis Associazione
• Contact: Antonio Dello Russo, MD
• Phone: +39 ?0715965798?
• Email: antonio.dellorusso[@]ospedaliriuniti.marche.it
• Is FDA regulated: No
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 51
• Est. completion date: October 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Esophageal Fistula
• Esophageal Perforation
• Fistula

Intervention

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
• 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

Locations

Country	Name	City	State
Italy	SOD di Cardiologia e Aritmologia	Ancona

Sponsors (2)

Lead Sponsor	Collaborator
Quovadis Associazione	Abbott

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Esophageal temperature by an esophageal continuous monitoring device	Celsius degree.	during AF ablation procedure
Secondary	ETI monitoring	Chronic (every 3 months until healing) evaluation of discovered ETI.	12 months after AF ablation procedure
Secondary	AF ablation procedure times	minutes	1 day
Secondary	AF recurrences	AF recurrences until 12 months after the ablation procedure	12 months after AF ablation procedure
Secondary	Serious and no serious adverse events	Serious and no serious adverse events after the ablation procedure	12 months after AF ablation procedure