Clinical trial NCT02665442: Retracting the Esophagus During AF Ablation
Official title: Esophageal Stylet as a Strategy to Minimize the Risk of Esophageal Injury During the Atrial Fibrillation Catheter Ablation Procedure.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Esophageal Fistula
Cardiac Arrhythmia
Keywords: Esophageal Stylet
EsoSure
Atrial Fibrillation
Catheter Ablation
Mechanical esophageal displacement
Lead sponsor: Northeast Scientific, Inc.
Sponsor class: INDUSTRY
First posted: 2016-01-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Esophageal injury or erosion
timeFrame: 2-3 days post ablation
Secondary outcomes:
measure: Recurrence of Atrial Fibrillation
timeFrame: 12 Months
measure: Total radiofrequency time
timeFrame: Day of ablation procedure
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Mark Marieb, MD, FACC
role: PRINCIPAL_INVESTIGATOR
References: