Atrial Fibrillation Clinical Trial
— ESO-SAFE-HP-RFOfficial title:
Esophageal Injury of a Tip CF Sensing Ablation Catheter for HP-SD of Paroxysmal and Persistent AF
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.
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. |
Country | Name | City | State |
---|---|---|---|
Italy | SOD di Cardiologia e Aritmologia | Ancona |
Lead Sponsor | Collaborator |
---|---|
Quovadis Associazione | Abbott |
Italy,
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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