Retracting the Esophagus During AF Ablation

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.

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.