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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Cardiac Arrhythmias, Atrial Fibrillation, Esophageal Ulcer

Intervention / Treatment
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* Device: multipolar and self expandable thermometer
* Device: Single probe thermometer


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial-esophageal fistula, radiofrequency ablation, Atrial Fibrillation ablation