Esophagus Imaging for Radiofrequency Ablation of Atrial Fibrillation

June 22, 2011 updated by: Luzerner Kantonsspital

Esophagus Imaging for Radiofrequency Ablation of Atrial Fibrillation: Comparison of Two Methods

As the left atrium is in close vicinity to the esophagus, radiofrequency ablation in the left atrium may damage the esophagus and create esophageal perforations and esophageal left atrial fistula. The aim of the present study is to compare different methods for visualization of the esophagus to prevent this complication.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Percutaneous catheter ablation with circumferential pulmonary vein isolation using radiofrequency energy has become an important therapeutic option to treat atrial fibrillation over the last years. Importing images from pre-acquired 3-D CT or MRI scans into the 3-D mapping system with superimposition of the electro-anatomical map is increasingly used. Despite these advances, the interventional electrophysiologist must be aware of potential complications that are associated with this procedure. As the left atrium is in close vicinity to the esophagus, radiofrequency ablation in the left atrium may damage the esophagus and create esophageal perforations and esophageal left atrial fistula. To prevent this lethal complication integration of an esophagus tag into the electroanatomic left atrium map visualizing the anatomic relationship has been studied und reported. Another possibility of visualization of the esophagus is to perform the CT after placing a conventional radio-opaque gastric tube, which provides information about the course of the esophagus in relation to the LA and may be scanned by CT . It has been shown that under normal conditions, if no barium is administered, there is little change in the anatomical relationship between the posterior left atrium and the esophagus during the entire cardiac cycle. However it is not clear whether the position of the esophagus in relation to the left atrium is changing over days.

The aim of the present study is to evaluate whether visualization of the esophagus by placing a conventional gastric tube before performing the CT scan and visualization and integration of the esophagus into the 3-D electro-anatomical map the day before ablation is accurate compared with integration of an esophagus tag into the electroanatomic left atrium map visualizing the anatomic relationship during the radiofrequency ablation.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Luzern, Switzerland, 6005
        • Kantonsspital Luzern, Department of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with atrial fibrillation undergoing radiofrequency ablation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Accuracy of localization of the esophagus in relation to the left atrium
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luzerner Kantonsspital

Investigators

  • Study Chair: Paul Erne, Luzerner Kantonsspital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

March 28, 2008

First Submitted That Met QC Criteria

April 1, 2008

First Posted (Estimate)

April 2, 2008

Study Record Updates

Last Update Posted (Estimate)

June 27, 2011

Last Update Submitted That Met QC Criteria

June 22, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Esophagus imaging

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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