Deviating the Esophagus in Atrial Fibrillation Ablation

Stopped early · Not applicable

Conditions studied: Esophageal Deviation, Atrial Fibrillation, Ablation

In brief

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.

Key facts

Study ID

NCT01546168

Run by

Vivek Reddy

People needed

88

Starts

2011-11-01

Expected to finish

2015-12-01

Last updated by the study team

2018-01-23

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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