Early Detection and Treatment of Esophageal Injury After Catheter Ablation for Atrial Fibrillation
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|ClinicalTrials.gov Identifier: NCT00584922|
Recruitment Status : Unknown
Verified March 2011 by University of Oklahoma.
Recruitment status was: Recruiting
First Posted : January 2, 2008
Last Update Posted : March 3, 2011
|Condition or disease||Intervention/treatment|
|Atrial Fibrillation||Procedure: Endoscopy in group I (all patients)|
The purpose of this study is to prospectively follow the next 200 patients who undergo catheter ablation of atrial fibrillation and endoscopy. If any signs of esophageal injury are seen on endoscopy the patients will be treated with omeprazole and sucralfate and they will have repeat endoscopy in two weeks. Patients who do not have any esophageal injury will be contacted by telephone in two weeks to be assessed for GI symptoms.
Specific Aims: The specific aims of the study are to:
- Assess the incidence of visible transmural esophageal injury following extensive ablation in the posterior left atrium as measured by endoscopy1
- Assess whether early detection of esophageal injury by endoscopy and treatment will prevent development of more serious injury such as left atrial-esophageal fistula
- Identify predictors of esophageal injury. In particular, to assess if esophageal temperature rises during ablation correlate with development of esophageal injury and if the absence of esophageal temperature rise during ablation correlate with the absence of esophageal injury.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Early Detection and Treatment of Esophageal Injury After Catheter Ablation for Atrial Fibrillation|
|Study Start Date :||January 2007|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||December 2011|
Patients undergoing catheter ablation of atrial fibrillation or left atrial macroreentrant tachycardia.
Procedure: Endoscopy in group I (all patients)
Post procedure endoscopy, omeprazole 40 mg BID, sucralfate 1 gm BID for 2-4 weeks.
- Incidence of esophageal injury as assessed by endoscopy [ Time Frame: 1 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00584922
|Contact: Karen Beckman, MD||405-271-9696 ext 37536||Karen-Beckman@ouhsc.edu|
|United States, Oklahoma|
|OU Medical Center||Recruiting|
|Oklahoma City, Oklahoma, United States, 73104|
|Principal Investigator: Karen Beckman, MD|
|Principal Investigator:||Karen Beckman, MD||University of Oklahoma|