Atrial fibrillation, esophageal ulcer, esophageal fistula, flutter and atrial fibrillation
Conditions
Interventions
Patients will be allocated 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:
Device
Sponsors
Hospital das Clínicas da Faculdade de Medicina da USP
Hospital das Clínicas da Faculdade de Medicina da USP
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients with paroxysmal or persistent AF, diagnosed by electrocardiogram, 24-hour Holter, or monitors of implantable or non-implantable events, with at least one episode of AF up to 12 months before the procedure. Patients should be willing and able to sign an informed consent form, and to undergo all procedures described in both the study protocol and the consent form.
Exclusion criteria
Exclusion criteria: Atrial thrombus in the left atrium; history of AF ablation; history of cardiac surgery; contraindication to anticoagulation; permanent AF; New York Heart Association functional class III or IV; stroke in the last 3 months; pregnancy, history blood clotting abnormalities; previous esophageal surgery; or advanced chronic kidney disease (creatinine > 2.5 mg/dl).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of esophageal lesions evaluated by upper digestive endoscopy within three days after the ablation procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of recurrence of AF at six months after ablation assessed by ECG, Holter 24 hours or clinically.;Isolation rate of pulmonary veins at the end of ablation.;Duration of the AF ablation procedure.Incidence of atrio-esophageal fistulas at six months.;Difference in the size of the esophageal lesions evaluated in the upper digestive endoscopy.;Persistence of esophageal lesions in the second upper endoscopy.;Maximum esophageal temperature reached during ablation. | — |
Countries
Brazil
Contacts
Public ContactDaniel Moura
Hospital das Clínicas da Faculdade de Medicina da USP
Outcome results
None listed