Retracting the Esophagus During AF Ablation

Not Applicable

• Conditions: Atrial Fibrillation; Esophageal Fistula; Cardiac Arrhythmia
• Interventions: Device: Esophageal Stylet - EsoSure

• Registration Number: NCT02665442
• Lead Sponsor: Northeast Scientific, Inc.

Brief 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.

Detailed 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 Timeline

• Status Verified: 2016-01
• Study Start: 2016-01
• Study First Submitted: 2016-01-23
• Study First Submitted QC: 2016-01-23
• Last Update Submitted: 2016-01-23
• Study First Posted: 2016-01-27
• Last Update Posted: 2016-01-27
• Primary Completion: 2018-01
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Age 18 or above for the Patient or legal representative to provide informed consent.
2. Documented paroxysmal or persistent Atrial Fibrillation by a Cardiologist and EKG finding.
3. The patient will undergo Atrial Fibrillation catheter ablation as a treatment plan.

Exclusion Criteria

1. Bleeding disorder.
2. Dysphagia to solid and liquid or any documented esophageal masses or cancer.
3. Esophageal varices, diverticulum, esophageal web, upper GI bleeding, or hiatal hernia.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stylet	Esophageal Stylet - EsoSure	This group will receive an Esophageal stylet; EsoSure during the ablation procedure in attempt of moving the esophagus away from the ablation site.

Primary Outcome Measures

Name	Time	Method
Esophageal injury or erosion	2-3 days post ablation	Decrease of esophageal thermal injury detected by esophageal Pill-Cam

Secondary Outcome Measures

Name	Time	Method
Total radiofrequency time	Day of ablation procedure	Decrease the total time of radiofrequency ablation at the procedure time
Recurrence of Atrial Fibrillation	12 Months	Decrease of atrial fibrillation recurrence after 12 months

Trial Locations

Locations (1)

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States