Atrial Fibrillation, Esophageal Fistula, Esophageal Perforation
Conditions
Keywords
esophageal thermal injury (ETI), AF ablation, high-power, short-duration (HP-SD), mini-invasive esophagoscopy
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).
Interventions
DEVICEmini-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
DEVICEHP-SD AF ablation by a CF sensing catheter
AF ablation session in an HP-SD setting and with a tip CF sensing ablation catheter
Sponsors
Abbott
Quovadis Associazione
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Pilot, about the safety, prospective, monocentric
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of the acute esophageal thermal injury (ETI) | 1-3 days after AF ablation procedure | Evaluate the acute proportion of the esophageal thermal injury (ETI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Esophageal temperature by an esophageal continuous monitoring device | during AF ablation procedure | Celsius degree. |
| ETI monitoring | 12 months after AF ablation procedure | Chronic (every 3 months until healing) evaluation of discovered ETI. |
| Factors influencing RF procedure on ETI development | 1-3 days after AF ablation procedure | Contribution of the factors influencing RF procedure (contact force, impedance, RF power, RF time) on ETI development |
| AF recurrences | 12 months after AF ablation procedure | AF recurrences until 12 months after the ablation procedure |
| Serious and no serious adverse events | 12 months after AF ablation procedure | Serious and no serious adverse events after the ablation procedure |
| AF ablation procedure times | 1 day | minutes |
Countries
Italy
Contacts
Primary ContactAntonio Dello Russo, MD
Backup ContactFranco Noventa, MD
Outcome results
None listed