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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05758805
Other study ID # ESO-SAFE-HP-RF Study
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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