Deviating the Esophagus in Atrial Fibrillation Ablation

Atrial Fibrillation Clinical Trial

Official title:

Esophageal Deviation in Atrial Fibrillation Ablation: A Randomized Control Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01546168
• Other study ID #: GCO 11-0909
• Status: Terminated
• Phase: N/A
• First received: February 13, 2012
• Last updated: January 19, 2018
• Start date: November 2011
• Est. completion date: December 2015

Study information

• Verified date: January 2018
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 88
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 ß-HCG test 7 days prior to procedure

Related Conditions & MeSH terms

• Ablation
• Atrial Fibrillation
• Esophageal Deviation

Intervention

Device:
• esophageal deviation with IDE device
esophageal deviation during AF ablation

Locations

Country	Name	City	State
United States	Texas Cardiac Arrhythmia Institute	Austin	Texas
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Florida Hospital	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Vivek Reddy	Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

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