Randomized Study on the Effect of Oesophageal Temperature on the Incidence of Esophageal Lesions After AF Ablation

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Cardiac Arrhythmias; Esophageal Ulcer
• Interventions: Device: multipolar and self expandable thermometer; Device: Single probe thermometer

• Registration Number: NCT03645070
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2017-07-11
• Study First Submitted: 2018-08-22
• Study First Submitted QC: 2018-08-22
• Study First Posted: 2018-08-24
• Primary Completion: 2018-10-01
• Study Completion: 2020-07-24
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-06
• Last Update Posted: 2022-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 oesophageal surgery, or advanced chronic kidney disease (creatinine > 2.5 mg/dl).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multi-probe	multipolar and self expandable thermometer	Twenty patients will be allocated in this group, in which there will be esophageal temperature monitoring during radiofrequency applications in the posterior wall of the left atrium, with a multipolar and self expandable thermometer.
Single probe thermometer	Single probe thermometer	Twenty patients will be allocated in this group, in which there will be monitoring of esophageal temperature during radiofrequency applications in the posterior wall of the left atrium, with unipolar thermometer.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Difference in the size of the esophageal lesions	Within three days	Difference in the size of the esophageal lesions evaluated in the upper digestive endoscopy according to the different groups
Isolation rate of pulmonary veins at the end of ablation.	End of the procedure	Will be assessed the rate of pulmonary veins isolation
Duration of the AF ablation procedure	End of the 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.
Rate of recurrence of AF	Six months	Rate of recurrence of AF after ablation assessed by ECG, Holter 24 hours or clinically.
Maximum esophageal temperature reached during ablation.	During procedure.	In the groups with esophageal temperature monitoring, the maximum esophageal temperature will be assessed and evaluated between two arms.
Incidence of atrio-esophageal fistulas	Six months	Incidence of atrio-esophageal fistulas after AF ablation
Persistence of esophageal lesions in the second upper endoscopy.	Between 3 to 30 days of the procedure	If necessary, the patients with esophageal lesions will be submitted to another upper endoscopy, and the persistence of esophageal lesions will be assessed

Trial Locations

Locations (1)

Arrhythmia Clinical Unit - Instituto do Coração - HCFMUSP; 🇧🇷 São Paulo, SP, Brazil