Retracting the Esophagus During AF Ablation

NCT02665442 | Unknown

• 1 other identifier: 1511016760
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Esophageal Fistula; Cardiac Arrhythmia

Keywords

Esophageal Stylet; EsoSure; Atrial Fibrillation; Catheter Ablation; Mechanical esophageal displacement

Outcome Measures

Primary Outcomes (1)

• Esophageal injury or erosion

  Decrease of esophageal thermal injury detected by esophageal Pill-Cam

  2-3 days post ablation

Secondary Outcomes (2)

• Recurrence of Atrial Fibrillation

  12 Months

• Total radiofrequency time

  Day of ablation procedure

Study Arms (2)

Stylet

EXPERIMENTAL

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

Non-Stylet

NO INTERVENTION

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

Interventions

Esophageal Stylet - EsoSure 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.

Also known as: Esophageal Retractor

Stylet

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or above for the Patient or legal representative to provide informed consent.
• Documented paroxysmal or persistent Atrial Fibrillation by a Cardiologist and EKG finding.
• The patient will undergo Atrial Fibrillation catheter ablation as a treatment plan.

You may not qualify if:

• Bleeding disorder.
• Dysphagia to solid and liquid or any documented esophageal masses or cancer.
• Esophageal varices, diverticulum, esophageal web, upper GI bleeding, or hiatal hernia.

Sponsors & Collaborators

• Northeast Scientific, Inc.: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Esophageal Fistula; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Digestive System Fistula; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Fistula; Pathological Conditions, Anatomical

Study Officials

• Mark Marieb, MD, FACC

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Medhat Abdelmessih, MD

CONTACT

(203) 737-1330; medhat.abdelmessih@yale.edu

Dawn Shaddinger, MSN, CCRN

CONTACT

(203) 737-3570; Dawn.Shaddinger@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2016
• First Posted: January 27, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: January 27, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)