Retracting the Esophagus During AF Ablation

Atrial Fibrillation Clinical Trial

— EsoSure  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02665442
• Other study ID #: 1511016760
• Status: Not yet recruiting
• Phase: N/A
• First received: January 23, 2016
• Last updated: January 23, 2016
• Start date: January 2016
• Est. completion date: January 2018

Study information

• Verified date: January 2016
• Source: Northeast Scientific, Inc.
• Contact: Medhat Abdelmessih, MD
• Phone: (203) 737-1330
• Email: medhat.abdelmessih[@]yale.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

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

Intervention

Device:
• Esophageal Stylet - EsoSure
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.

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Northeast Scientific, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Esophageal injury or erosion	Decrease of esophageal thermal injury detected by esophageal Pill-Cam	2-3 days post ablation	Yes
Secondary	Recurrence of Atrial Fibrillation	Decrease of atrial fibrillation recurrence after 12 months	12 Months	No
Secondary	Total radiofrequency time	Decrease the total time of radiofrequency ablation at the procedure time	Day of ablation procedure	No