It's a randomized pilot study to evaluate the incidence of esophageal thermal injury after left atrial ablation for the treatment of atrial fibrillation according to three different strategies of esophageal temperature monitoring. These patients will be divided into 3 groups with different strategies of esophageal temperature monitoring: group 1 without monitoring, group 2 monitoring with single probe thermometer and group 3 monitoring with multi-probe thermometer. The primary end point will be the incidence of esophageal lesions assessed by upper endoscopy.
This is a randomized pilot study on the effect of oesophageal temperature monitoring on the esophageal thermal injury after left atrial ablation for the treatment of atrial fibrillation (AF). Sixty patients with paroxysmal AF or persistent and without previous AF ablation with indication of AF ablation will be selected to be included at the study. After informed consent, these patients will be randomized in 3 groups with different strategies of esophageal protection for radiofrequency application in the posterior wall of the left atrium, by randomization in a ratio of 1: 1: 1 between groups. Group I: no esophageal temperature monitoring technique. Group II: monitoring of esophageal temperature during radiofrequency applications in the posterior wall of the left atrium, with unipolar thermometer. Group III: oesophageal temperature monitoring during radiofrequency applications in the posterior wall of the left atrium, with a multipolar and self expandable thermometer. The primary end point will be the incidence of esophageal lesions assessed by upper endoscopy that will be done in all patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
60
Will be evaluated if a multipolar and self expandable thermometer is superior to no probe or to single probe thermometer at prevention of esophageal thermal injury.
Will be evaluated if a single probe thermometer is superior to a multipolar and self expandable thermometer or to no probe thermometer at prevention of esophageal thermal injury
Arrhythmia Clinical Unit - Instituto do Coração - HCFMUSP
São Paulo, São Paulo, Brazil
Incidence of esophageal lesions
Incidence of esophageal lesions evaluated by upper digestive endoscopy
Time frame: Within three days after the ablation procedure.
Rate of recurrence of AF
Rate of recurrence of AF after ablation assessed by ECG, Holter 24 hours or clinically.
Time frame: Six months
Isolation rate of pulmonary veins at the end of ablation.
Will be assessed the rate of pulmonary veins isolation
Time frame: End of the procedure
Duration of the AF ablation procedure
Will be assessed the duration of the AF ablation that will start at the time of the first radio-frequency lesion until the last one.
Time frame: End of the procedure
Incidence of atrio-esophageal fistulas
Incidence of atrio-esophageal fistulas after AF ablation
Time frame: Six months
Difference in the size of the esophageal lesions
Difference in the size of the esophageal lesions evaluated in the upper digestive endoscopy according to the different groups
Time frame: Within three days
Persistence of esophageal lesions in the second upper endoscopy.
If necessary, the patients with esophageal lesions will be submitted to another upper endoscopy, and the persistence of esophageal lesions will be assessed
Time frame: Between 3 to 30 days of the procedure
Maximum esophageal temperature reached during ablation.
In the groups with esophageal temperature monitoring, the maximum esophageal temperature will be assessed and evaluated between two arms.
Time frame: During procedure.
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