Esophagus Imaging for Radiofrequency Ablation of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00650728
• Other study ID #: Esophagus imaging
• Status: Completed
• Phase: N/A
• First received: March 28, 2008
• Last updated: June 22, 2011
• Start date: March 2008
• Est. completion date: May 2009

Study information

• Verified date: June 2011
• Source: Luzerner Kantonsspital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with atrial fibrillation undergoing radiofrequency ablation

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• placing gastric tube

Locations

Country	Name	City	State
Switzerland	Kantonsspital Luzern, Department of Cardiology	Luzern

Sponsors (1)

Lead Sponsor	Collaborator
Luzerner Kantonsspital

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of localization of the esophagus in relation to the left atrium		one year