Retracting the Esophagus During AF Ablation (EsoSure)

Northeast Scientific, Inc.

Status: Unknown

Conditions: Atrial Fibrillation; Cardiac Arrhythmia; Esophageal Fistula

Treatments: Device: Esophageal Stylet - EsoSure

Study type: Interventional

Funder types: Industry

Identifiers

NCT02665442

1511016760

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

Stylet

Experimental group

Description:

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

Treatment:

Device: Esophageal Stylet - EsoSure

Non-Stylet

No Intervention group

Description:

This group will receive the ablation procedure without any modifications or interventions. No esophageal stylet will be used in this group.