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Esophageal Deviation in Atrial Fibrillation Ablation

January 24, 2020

Overview

Ablation treatment in the posterior wall of the left atrium can cause thermal injury to the esophagus, which is a very common occurrence. The goal of this study is to measure the safety of moving the esophagus with a specialized tool (DV8 esophageal deviation tool). The study aims to determine if this tool is more effective and feasible than other types of deviation equipment.

 

Study Information

64 subjects will be enrolled in the study. The primary purpose of the trial is prevention. The study began on November 17, 2017 and is estimated to be completed by August 30, 2020.

 

Inclusion Criteria

 

  • A maximum of up to 54 patients will be enrolled in this prospective single-center single-arm study. Patients undergoing AF ablation (including paroxysmal and persistent AF) will be included in this study. Consistent with the current definitions, paroxysmal AF are episodes that will self-terminate in less than 24 hours. Persistent AF is defined as ≥1 documented AF lasting >1week in duration or lasting less than 7 days but requiring electrical or pharmacological cardioversion to sinus rhythm.
  • Age >18 – Age < 80 yr
  • Documentation of atrial fibrillation (AF)
  • 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, varices, bleeding, laceration or perforation, esophagitis
  • Severe GERD
  • H/o esophageal surgery or any esophageal banding or cautery
  • H/o chest radiation
  • 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 within 7 days prior to procedure
  • Presence of left atrial thrombus

 

Location

This study will take place at the Massachusetts General Hospital, Boston, Massachusetts, United States, 02114. If you have any questions, please contact Grace Ha at 617-643-1697 / gha2@mgh.harvard.edu.

 

Sponsors / Collaborators

This study is sponsored by the Massachusetts General Hospital. The principal investigator is Moussa C Mansour of the Massachusetts General Hospital.

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