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

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.

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Cardiac Arrhythmias; Esophageal Ulcer
• Intervention / Treatment: Device: Single probe thermometer; Device: multipolar and self expandable thermometer

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 05403010
      • Arrhythmia Clinical Unit - Instituto do Coração - HCFMUSP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No probe; Twenty patients will be allocated to this group, which will have no esophageal temperature monitoring technique
Active Comparator: 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.	Device: 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
Active Comparator: Multi-probe; 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.	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.; Other Names: CIRCA's S-CATH™ Esophageal Temperature Monitoring System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of esophageal lesions	Incidence of esophageal lesions evaluated by upper digestive endoscopy	Within three days after the ablation procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of recurrence of AF	Rate of recurrence of AF after ablation assessed by ECG, Holter 24 hours or clinically.	Six months
Isolation rate of pulmonary veins at the end of ablation.	Will be assessed the rate of pulmonary veins isolation	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.	End of the procedure
Incidence of atrio-esophageal fistulas	Incidence of atrio-esophageal fistulas after AF ablation	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	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	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.	During procedure.

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Collaborators: Circa Scientific
• Investigators: Principal Investigator: Mauricio I Scanavacca, MD, PhD, Instituto do coração - HC/FMUSP

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2017
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): July 24, 2020

Study Registration Dates

• First Submitted: August 22, 2018
• First Submitted That Met QC Criteria: August 22, 2018
• First Posted (Actual): August 24, 2018

Study Record Updates

• Last Update Posted (Actual): January 10, 2022
• Last Update Submitted That Met QC Criteria: January 6, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: radiofrequency ablation; Atrial Fibrillation ablation; atrial-esophageal fistula
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Atrial Fibrillation; Arrhythmias, Cardiac
• Other Study ID Numbers: Arrit-Incor-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes