Deviating the Esophagus in Atrial Fibrillation Ablation

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Mount Sinai School of Medicine
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: December 19, 2013
Last verified: December 2013

February 13, 2012
December 19, 2013
November 2011
December 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01546168 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
  • Esophageal Deviation
  • Atrial Fibrillation
  • Ablation
Procedure: esophageal deviation
esophageal deviation during AF ablation
  • Experimental: esophageal deviation
    esophageal deviation during AF ablation
    Intervention: Procedure: esophageal deviation
  • No Intervention: temperature monitoring
    luminal esophageal temperature monitoring, standard temperature monitoring alone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
230
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Betsy A Ellsworth, MSN, ANP 212-824-8902 betsy.ellsworth@mountsinai.org
United States
 
NCT01546168
GCO 11-0909
Yes
Vivek Reddy, Mount Sinai School of Medicine
Vivek Reddy
Boston Scientific Corporation
Principal Investigator: Vivek Reddy, MD Mount Sinai School of Medicine
Mount Sinai School of Medicine
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP