Retracting the Esophagus During AF Ablation (EsoSure)

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

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation; Cardiac Arrhythmia; Esophageal Fistula
• Intervention / Treatment: Device: Esophageal Stylet - EsoSure

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Medhat Abdelmessih, MD; Phone Number: (203) 737-1330; Email: medhat.abdelmessih@yale.edu
• Study Contact Backup: Name: Dawn Shaddinger, MSN, CCRN; Phone Number: (203) 737-3570; Email: Dawn.Shaddinger@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale New Haven Hospital
      • Contact: Medhat Abdelmessih, MD; Phone Number: 203-737-1330; Email: medhat.abdelmessih@yale.edu
      • Principal Investigator: Mark Marieb, MD, FACC
      • Sub-Investigator: Medhat Abdelmessih, MD
      • Sub-Investigator: Ralph Ralph Debiasi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stylet; This group will receive an Esophageal stylet; EsoSure during the ablation procedure in attempt of moving the esophagus away from the ablation site.	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.; Other Names: Esophageal Retractor
No Intervention: Non-Stylet; This group will receive the ablation procedure without any modifications or interventions. No esophageal stylet will be used in this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Esophageal injury or erosion	Decrease of esophageal thermal injury detected by esophageal Pill-Cam	2-3 days post ablation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of Atrial Fibrillation	Decrease of atrial fibrillation recurrence after 12 months	12 Months
Total radiofrequency time	Decrease the total time of radiofrequency ablation at the procedure time	Day of ablation procedure

Collaborators and Investigators

• Sponsor: Northeast Scientific, Inc.
• Investigators: Principal Investigator: Mark Marieb, MD, FACC, Yale University

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: January 23, 2016
• First Submitted That Met QC Criteria: January 23, 2016
• First Posted (Estimate): January 27, 2016

Study Record Updates

• Last Update Posted (Estimate): January 27, 2016
• Last Update Submitted That Met QC Criteria: January 23, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Catheter Ablation; Esophageal Stylet; EsoSure; Mechanical esophageal displacement
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Gastrointestinal Diseases; Pathological Conditions, Anatomical; Esophageal Diseases; Digestive System Fistula; Atrial Fibrillation; Fistula; Arrhythmias, Cardiac; Esophageal Fistula
• Other Study ID Numbers: 1511016760

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data will be shared through publications.