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Deviating the Esophagus in Atrial Fibrillation Ablation

Primary Purpose

Esophageal Deviation, Atrial Fibrillation, Ablation

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
esophageal deviation with IDE device
Sponsored by
Vivek Reddy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Esophageal Deviation focused on measuring Atrial Fibrillation ablation, Esophageal Deviation, AF

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Florida Hospital
  • Massachusetts General Hospital
  • Icahn School of Medicine at Mount Sinai
  • Texas Cardiac Arrhythmia Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

esophageal deviation

temperature monitoring

Arm Description

esophageal deviation with IDE device during AF ablation

luminal esophageal temperature monitoring, standard temperature monitoring alone

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Procedure Time
Procedure time and fluoroscopic imaging with barium contrast time
Temperature
Extent of temperature rise on the temperature monitoring probe
Swallowing Impairment Score
Swallowing impairment during procedure - Scale from 0 (no impairment) to 4 (severe impairment).

Full Information

First Posted
February 13, 2012
Last Updated
January 19, 2018
Sponsor
Vivek Reddy
Collaborators
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01546168
Brief Title
Deviating the Esophagus in Atrial Fibrillation Ablation
Official Title
Esophageal Deviation in Atrial Fibrillation Ablation: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
Interim analysis: no statistically significant difference in the 2 study arms.
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Vivek Reddy
Collaborators
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Deviation, Atrial Fibrillation, Ablation
Keywords
Atrial Fibrillation ablation, Esophageal Deviation, AF

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
esophageal deviation
Arm Type
Experimental
Arm Description
esophageal deviation with IDE device during AF ablation
Arm Title
temperature monitoring
Arm Type
No Intervention
Arm Description
luminal esophageal temperature monitoring, standard temperature monitoring alone
Intervention Type
Device
Intervention Name(s)
esophageal deviation with IDE device
Intervention Description
esophageal deviation during AF ablation
Primary Outcome Measure Information:
Title
Number of Participants With Presence of Esophageal Injury
Description
The presence of esophageal injury as assessed by upper gastrointestinal endoscopy that is performed within 1 week of the procedure.
Time Frame
within 1 week of AF ablation procedure
Secondary Outcome Measure Information:
Title
Procedure Time
Description
Procedure time and fluoroscopic imaging with barium contrast time
Time Frame
day 1, duration ofAF ablation procedure
Title
Temperature
Description
Extent of temperature rise on the temperature monitoring probe
Time Frame
during AF ablation procedure (intraoperative)
Title
Swallowing Impairment Score
Description
Swallowing impairment during procedure - Scale from 0 (no impairment) to 4 (severe impairment).
Time Frame
during AF ablation procedure (intraoperative)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivek Reddy, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Texas Cardiac Arrhythmia Institute
City
Austin
State/Province
Texas
ZIP/Postal Code
78075
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Deviating the Esophagus in Atrial Fibrillation Ablation

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