Clinical trial NCT01546168: Deviating the Esophagus in Atrial Fibrillation Ablation
Official title: Esophageal Deviation in Atrial Fibrillation Ablation: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Esophageal Deviation
Atrial Fibrillation
Ablation
Keywords: Atrial Fibrillation ablation
Esophageal Deviation
AF
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2012-03-07
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of Participants With Presence of Esophageal Injury
timeFrame: within 1 week of AF ablation procedure
Secondary outcomes:
measure: Procedure Time
timeFrame: day 1, duration ofAF ablation procedure
measure: Temperature
timeFrame: during AF ablation procedure (intraoperative)
measure: Swallowing Impairment Score
timeFrame: during AF ablation procedure (intraoperative)
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Institute
state: Texas
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Vivek Reddy, MD
role: PRINCIPAL_INVESTIGATOR
References: