Clinical trial NCT05758805: Esophageal Injury of a Tip CF Sensing Ablation Catheter for HP-SD of Paroxysmal and Persistent AF (ESO-SAFE-HP-RF)
Official title: Esophageal Injury of a Tip CF Sensing Ablation Catheter for HP-SD of Paroxysmal and Persistent AF
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Esophageal Perforation
Esophageal Fistula
Keywords: esophageal thermal injury (ETI)
AF ablation
high-power, short-duration (HP-SD)
mini-invasive esophagoscopy
Lead sponsor: Quovadis Associazione
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2023-03-07
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot, about the safety, prospective, monocentric
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Proportion of the acute esophageal thermal injury (ETI)
timeFrame: 1-3 days after AF ablation procedure
Secondary outcomes:
measure: Factors influencing RF procedure on ETI development
timeFrame: 1-3 days after AF ablation procedure
measure: Esophageal temperature by an esophageal continuous monitoring device
timeFrame: during AF ablation procedure
measure: ETI monitoring
timeFrame: 12 months after AF ablation procedure
measure: AF ablation procedure times
timeFrame: 1 day
measure: AF recurrences
timeFrame: 12 months after AF ablation procedure
measure: Serious and no serious adverse events
timeFrame: 12 months after AF ablation procedure
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: SOD di Cardiologia e Aritmologia
Study officials:
affiliation: Cardiology and Arrhythmology Dept., Azienda Ospedaliero Universitaria delle Marche, Ancona (Italy)
name: Antonio Dello Russo, MD
role: PRINCIPAL_INVESTIGATOR
References: