Study on the effect of Esophageal Temperature on the incidence of Esophageal Lesions after Atrial Fibrillation Ablatio

Not Applicable

• Conditions: Atrial fibrillation, esophageal ulcer, esophageal fistula, flutter and atrial fibrillation; C14.280.067.198; C06.267.250; C23.550.891

• Registration Number: RBR-2yvgyf
• Lead Sponsor: Hospital das Clínicas da Faculdade de Medicina da USP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-05
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

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

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).

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of esophageal lesions evaluated by upper digestive endoscopy within three days after the ablation procedure.

Secondary Outcome Measures

Name	Time	Method
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.