Deviating the Esophagus in Atrial Fibrillation Ablation

Esophageal Deviation in Atrial Fibrillation Ablation: A Randomized Control Trial

In this randomized double-blind study, the investigators would like to compare standard practice (i.e., use of luminal esophageal temperature monitoring) to that of esophageal deviation during AF ablation. The investigators hypothesize that the strategy of esophageal deviation will result in safer ablation strategy with a reduction in the incidence of esophageal injury as assessed by endoscopy.

Study Overview

• Status: Terminated
• Conditions: Atrial Fibrillation; Ablation; Esophageal Deviation
• Intervention / Treatment: Device: esophageal deviation with IDE device

Detailed Description

Catheter ablation is a commonly performed strategy employed for the treatment of atrial fibrillation. However ablation in the posterior wall of the left atrium can cause thermal injury to the esophagus. When significant thermal injury to the esophagus occurs, two significant complications can occur: 1) the formation of an atrio-esophageal fistula, and 2) gastrointestinal dysmotility. While the former is rate, it is an important complication since it can be fatal. The frequency of the latter complication is less well appreciated, but probably occurs in the range of 1:100 to 1:500. Currently luminal esophageal temperature monitoring is the most commonly employed modality to prevent such injury. However, there are limitations to its use, and atrio-esophageal fistulas have been reported even when using esophageal temperature monitoring. Esophageal deviation using either a TEE or EGD probe has been described in the literature, but the effectiveness and practicality of these techniques are suboptimal, and have therefore precluded their use in routine clinical practice. Recently, we have demonstrated that esophageal deviation is indeed possible using off-the-shelf equipment (a soft thoracic tube and endotracheal stylet) in patients undergoing AF ablation. In this randomized double-blind study, we will compare standard practice (i.e., use of luminal esophageal temperature monitoring) to esophageal deviation during AF ablation. We hypothesize that the strategy of esophageal deviation will result in safer ablation strategy with a reduction in the incidence of esophageal injury as assessed by endoscopy.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32803
      • Florida Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
  • Texas
    • Austin, Texas, United States, 78075
      • Texas Cardiac Arrhythmia Institute

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:

• Age >18 - Age < 80 yr
• Documentation of atrial fibrillation (AF)
• Referred for a first ever ablation procedure for AF (prior ablation of right-sided Typical flutter, or "limited" left-sided of an accessory pathway are permitted)
• General anesthesia
• All patients must understand and adhere to the requirements of the study and be willing to comply with the post study follow-up requirements.

Exclusion Criteria:

• Any reversible cause of AF (post-surgery, thyroid disorder, etc.)
• INR > 4.0 at the time of the procedure
• H/o of severe esophageal ulcers, strictures, esophagitis or GERD
• H/o Esophageal Surgery
• Prior surgical or catheter ablation procedure for AF (except right atrial flutter ablation)
• Any evidence of esophageal diverticulum or other structural abnormalities of the esophagus seen during baseline barium esophagogram
• Significant abnormality on Swallowing Impairment Score
• Mental impairment precluding signing consent or completing follow up
• Patients with any other significant uncontrolled or unstable medical condition
• Women who are known to be pregnant or have had a positive β-HCG test 7 days prior to procedure

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: esophageal deviation; esophageal deviation with IDE device during AF ablation	Device: esophageal deviation with IDE device; esophageal deviation during AF ablation
No Intervention: temperature monitoring; luminal esophageal temperature monitoring, standard temperature monitoring alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Presence of Esophageal Injury	The presence of esophageal injury as assessed by upper gastrointestinal endoscopy that is performed within 1 week of the procedure.	within 1 week of AF ablation procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure Time	Procedure time and fluoroscopic imaging with barium contrast time	day 1, duration ofAF ablation procedure
Temperature	Extent of temperature rise on the temperature monitoring probe	during AF ablation procedure (intraoperative)
Swallowing Impairment Score	Swallowing impairment during procedure - Scale from 0 (no impairment) to 4 (severe impairment).	during AF ablation procedure (intraoperative)

Collaborators and Investigators

• Sponsor: Vivek Reddy
• Collaborators: Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: February 13, 2012
• First Submitted That Met QC Criteria: March 1, 2012
• First Posted (Estimate): March 7, 2012

Study Record Updates

• Last Update Posted (Actual): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 19, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: AF; Atrial Fibrillation ablation; Esophageal Deviation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: GCO 11-0909

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO