Deviating the Esophagus in Atrial Fibrillation Ablation

This study has been terminated.
(Interim analysis: no statistically significant difference in the 2 study arms.)
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Vivek Reddy, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01546168
First received: February 13, 2012
Last updated: February 23, 2015
Last verified: February 2015
  Purpose

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.


Condition Intervention
Esophageal Deviation
Atrial Fibrillation
Ablation
Device: esophageal deviation with IDE device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Esophageal Deviation in Atrial Fibrillation Ablation: A Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • presence of esophageal injury [ Time Frame: within 1 week of AF ablation procedure ] [ Designated as safety issue: Yes ]
    The presence of esophageal injury as assessed by upper gastrointestinal endoscopy that is performed within 1 week of the procedure.


Secondary Outcome Measures:
  • Esophageal deviation [ Time Frame: baseline and anytime from 1 day-1 week post AF ablation procedure follow-up ] [ Designated as safety issue: No ]
    Extent of esophageal deviation on comparison to the baseline position as measured on fluoroscopic imaging with barium contrast

  • Temperature [ Time Frame: during AF ablation procedure (intraoperative) ] [ Designated as safety issue: No ]
    Extent of temperature rise on the temperature monitoring probe

  • Swallowing impairment score [ Time Frame: baseline. during AF ablation procedure (intraoperative). 1 day to 1 week post procedure. and 2 week to 3 month post procedure ] [ Designated as safety issue: No ]
    comparison in change in swallowing impairment from baseline, during procedure, 1 day to 1 week post procedure, and 2 week to 3 month post procedure.


Enrollment: 88
Study Start Date: November 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: esophageal deviation
esophageal deviation 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01546168

Locations
United States, Florida
Florida Hospital
Orlando, Florida, United States, 32803
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
United States, Texas
Texas Cardiac Arrhythmia Institute
Austin, Texas, United States, 78075
Sponsors and Collaborators
Vivek Reddy
Boston Scientific Corporation
Investigators
Principal Investigator: Vivek Reddy, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Vivek Reddy, Director Cardiac Arrhythmia Service, Professor of Medicine, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01546168     History of Changes
Other Study ID Numbers: GCO 11-0909
Study First Received: February 13, 2012
Last Updated: February 23, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Mount Sinai School of Medicine:
Atrial Fibrillation ablation
Esophageal Deviation
AF

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 19, 2015