Retracting the Esophagus During AF Ablation

NCT ID: NCT02665442

Last Updated: 2016-01-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-01-31

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.

Conditions

Atrial Fibrillation; Esophageal Fistula; Cardiac Arrhythmia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Stylet

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

Group Type: EXPERIMENTAL

Esophageal Stylet - EsoSure

Intervention Type: DEVICE

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.

Non-Stylet

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Esophageal Retractor

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northeast Scientific, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Marieb, MD, FACC

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale New Haven Hospital

New Haven, Connecticut, United States

Countries

United States

Central Contacts

Medhat Abdelmessih, MD

Role: CONTACT

medhat.abdelmessih@yale.edu

(203) 737-1330

Dawn Shaddinger, MSN, CCRN

Role: CONTACT

Dawn.Shaddinger@yale.edu

(203) 737-3570

Facility Contacts

Medhat Abdelmessih, MD

Role: primary

medhat.abdelmessih@yale.edu

203-737-1330

Other Identifiers

1511016760

Identifier Type: -

Identifier Source: org_study_id