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Esophagus Imaging for Radiofrequency Ablation of Atrial Fibrillation

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
placing gastric tube
Sponsored by
Luzerner Kantonsspital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation focused on measuring radiofrequency ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with atrial fibrillation undergoing radiofrequency ablation

Sites / Locations

  • Kantonsspital Luzern, Department of Cardiology

Outcomes

Primary Outcome Measures

Accuracy of localization of the esophagus in relation to the left atrium

Secondary Outcome Measures

Full Information

First Posted
March 28, 2008
Last Updated
June 22, 2011
Sponsor
Luzerner Kantonsspital
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1. Study Identification

Unique Protocol Identification Number
NCT00650728
Brief Title
Esophagus Imaging for Radiofrequency Ablation of Atrial Fibrillation
Official Title
Esophagus Imaging for Radiofrequency Ablation of Atrial Fibrillation: Comparison of Two Methods
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Luzerner Kantonsspital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
radiofrequency ablation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
placing gastric tube
Primary Outcome Measure Information:
Title
Accuracy of localization of the esophagus in relation to the left atrium
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with atrial fibrillation undergoing radiofrequency ablation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Erne
Organizational Affiliation
Luzerner Kantonsspital
Official's Role
Study Chair
Facility Information:
Facility Name
Kantonsspital Luzern, Department of Cardiology
City
Luzern
ZIP/Postal Code
6005
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
19757002
Citation
Kobza R, Schoenenberger AW, Erne P. Esophagus imaging for catheter ablation of atrial fibrillation: comparison of two methods with showing of esophageal movement. J Interv Card Electrophysiol. 2009 Dec;26(3):159-64. doi: 10.1007/s10840-009-9434-3. Epub 2009 Sep 10.
Results Reference
background

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Esophagus Imaging for Radiofrequency Ablation of Atrial Fibrillation

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