Retracting the Esophagus During AF Ablation — EsoSure  

Atrial Fibrillation Clinical Trial

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

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Cardiac Arrhythmia
• Esophageal Fistula

• NCT number: NCT02665442
• Study type: Interventional
• Source: Northeast Scientific, Inc.
• Contact: Medhat Abdelmessih, MD
• Phone: (203) 737-1330
• Email: medhat.abdelmessih@yale.edu
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2016
• Completion date: January 2018