Deviating the Esophagus in Atrial Fibrillation Ablation

NCT ID: NCT01546168

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2015-12-31

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.

Conditions

Esophageal Deviation; Atrial Fibrillation; Ablation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

esophageal deviation

esophageal deviation with IDE device during AF ablation

Group Type: EXPERIMENTAL

esophageal deviation with IDE device

Intervention Type: DEVICE

esophageal deviation during AF ablation

temperature monitoring

luminal esophageal temperature monitoring, standard temperature monitoring alone

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

esophageal deviation with IDE device

esophageal deviation during AF ablation

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

Vivek Reddy

OTHER

Sponsor Role: lead

Responsible Party

Vivek Reddy

Director Cardiac Arrhythmia Service, Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Vivek Reddy, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Florida Hospital

Orlando, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Texas Cardiac Arrhythmia Institute

Austin, Texas, United States

Countries

United States

Other Identifiers

GCO 11-0909

Identifier Type: -

Identifier Source: org_study_id