Esophageal Injury of a Tip CF Sensing Ablation Catheter for HP-SD of Paroxysmal and Persistent AF (ESO-SAFE-HP-RF)
Esophageal Injury of a Tip CF Sensing Ablation Catheter for HP-SD of Paroxysmal and Persistent AF
Quovadis Associazione
51 participants
Jan 8, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- 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.
- Able to sign the consent form.
Exclusion Criteria15
- LVEF \< 45%
- Presence of thrombus in the left atrium
- NYHA III/IV Class
- Atrial diameter \> 50mm
- Moderate or severe valve dysfunction
- Implanted ICD/CRT-D
- Life expectancy \< 1 year
- Uncontrolled Hyperthyroidism
- Hypertrophic or dilatative cardiomyopathy
- Kidney failure (eGFR \< 30)
- Body Mass Index (BMI)\> or = 35
- Participation in another clinical trial in the past 3 months
- Inability to express informed consent for the study
- Patients with esophageal pathologies and a history of gastritis
- 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.
Interventions
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
AF ablation session in an HP-SD setting and with a tip CF sensing ablation catheter
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05758805