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Esophagus Imaging for Radiofrequency Ablation of Atrial Fibrillation
This study is currently recruiting participants.
Verified by Kantonsspital Luzern, February 2008
First Received: March 28, 2008   Last Updated: April 1, 2008   History of Changes
Sponsored by: Kantonsspital Luzern
Information provided by: Kantonsspital Luzern
ClinicalTrials.gov Identifier: NCT00650728
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Procedure: placing gastric tube

Study Type: Interventional
Study Design: Diagnostic, Open Label, Single Group Assignment
Official Title: Esophagus Imaging for Radiofrequency Ablation of Atrial Fibrillation: Comparison of Two Methods

Resource links provided by NLM:


Further study details as provided by Kantonsspital Luzern:

Primary Outcome Measures:
  • Accuracy of localization of the esophagus in relation to the left atrium [ Time Frame: one year ]

Study Start Date: March 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with atrial fibrillation undergoing radiofrequency ablation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00650728

Contacts
Contact: Paul Erne, MD ++41 41 205 52 08 paul.erne@ksl.ch

Locations
Switzerland
Kantonsspital Luzern, Department of Cardiology Recruiting
Luzern, Switzerland, 6005
Contact: Paul Erne, MD     ++41 41 205 52 08     paul.erne@ksl.ch    
Sub-Investigator: Richard Kobza, MD            
Principal Investigator: Paul Erne, MD            
Sponsors and Collaborators
Kantonsspital Luzern
Investigators
Study Chair: Paul Erne Kantonsspital Luzern
  More Information

No publications provided

Study ID Numbers: Esophagus imaging
Study First Received: March 28, 2008
Last Updated: April 1, 2008
ClinicalTrials.gov Identifier: NCT00650728     History of Changes
Health Authority: Switzerland: Ethikkommission

Keywords provided by Kantonsspital Luzern:
radiofrequency ablation

Study placed in the following topic categories:
Heart Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on September 11, 2009