Retracting the Esophagus During AF Ablation

Study Overview
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Brief Summary
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This Study is designed to determine the outcome and effect of implementation of Esophageal Stylet as a strategy to minimize the risk of esophageal injury during the atrial fibrillation catheter ablation procedure.

Detailed Description
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There is a clear potential to produce transmural esophageal injury during catheter ablation for AF when employing a lesion set targeting the posterior left atrial wall and pulmonary vein (PV) antra using contemporary large-tip or irrigated-tip catheter ablation systems when endocardial target sites are in close proximity to the esophagus. It is very likely that a movement by the Esophageal Stylet of only 2 to 3 centimeters from the midline can safely protect the esophagus from thermal injury and will mimic the natural migration of the esophagus itself. The Stylet proposes to safely facilitate lateral esophageal movement in a manner consistent with the esophagus's own natural migration in order to displace and maintain the esophagus's position away from potential damage resulting from a cardiac ablation procedure in the left atrium or coronary sinus. The Esophageal Stylet is a thin rigid tube, which will be inserted inside a commonly used nasogastric tube placed inside the esophagus during the ablation. We will use this stylet to move the esophagus away from the site of the ablation about 1-2 centimeters. Other common procedures, such as (Trans-esophageal Echocardiogram), move the esophagus twice this distance with a low risk.

Official Title
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Esophageal Stylet as a Strategy to Minimize the Risk of Esophageal Injury During the Atrial Fibrillation Catheter Ablation Procedure.

Conditions
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Atrial Fibrillation, Esophageal Fistula, Cardiac Arrhythmia

Intervention / Treatment
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* Device: Esophageal Stylet - EsoSure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or above for the Patient or legal representative to provide informed consent. Documented paroxysmal or persistent Atrial Fibrillation by a Cardiologist and EKG finding. The patient will undergo Atrial Fibrillation catheter ablation as a treatment plan. Exclusion Criteria: Bleeding disorder. Dysphagia to solid and liquid or any documented esophageal masses or cancer. Esophageal varices, diverticulum, esophageal web, upper GI bleeding, or hiatal hernia.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stylet<br>This group will receive an Esophageal stylet; EsoSure during the ablation procedure in attempt of moving the esophagus away from the ablation site. | Device: Esophageal Stylet - EsoSure<br>* The Esophageal Stylet is a thin rigid tube, which will be inserted inside a commonly used nasogastric tube placed inside the esophagus during the ablation. We will use this stylet to move the esophagus away from the site of the ablation about 1-2 centimeters.<br>* Other names: Esophageal Retractor;|
| No Intervention: Non-Stylet<br>This group will receive the ablation procedure without any modifications or interventions. No esophageal stylet will be used in this group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esophageal injury or erosion | Decrease of esophageal thermal injury detected by esophageal Pill-Cam | 2-3 days post ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of Atrial Fibrillation | Decrease of atrial fibrillation recurrence after 12 months | 12 Months | 
| Total radiofrequency time | Decrease the total time of radiofrequency ablation at the procedure time | Day of ablation procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal Stylet, EsoSure, Atrial Fibrillation, Catheter Ablation, Mechanical esophageal displacement