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

Atrial Fibrillation Clinical Trial

Official title:

A Prospective Randomized Study on the Effect of Oesophageal Temperature Monitoring on the Incidence of Esophageal Lesions After Left Atrial Ablation for the Treatment of Atrial Fibrillation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03645070
• Other study ID #: Arrit-Incor-2
• Status: Completed
• Phase: N/A
• Start date: July 11, 2017
• Est. completion date: July 24, 2020

Study information

• Verified date: January 2022
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 24, 2020
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Cardiac Arrhythmias
• Esophageal Ulcer

Intervention

Device:
• multipolar and self expandable thermometer
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.
• Single probe thermometer
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

Locations

Country	Name	City	State
Brazil	Arrhythmia Clinical Unit - Instituto do Coração - HCFMUSP	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Circa Scientific

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of esophageal lesions	Incidence of esophageal lesions evaluated by upper digestive endoscopy	Within three days after the ablation procedure.
Secondary	Rate of recurrence of AF	Rate of recurrence of AF after ablation assessed by ECG, Holter 24 hours or clinically.	Six months
Secondary	Isolation rate of pulmonary veins at the end of ablation.	Will be assessed the rate of pulmonary veins isolation	End of the procedure
Secondary	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.	End of the procedure
Secondary	Incidence of atrio-esophageal fistulas	Incidence of atrio-esophageal fistulas after AF ablation	Six months
Secondary	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	Within three days
Secondary	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	Between 3 to 30 days of the procedure
Secondary	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.	During procedure.