Early Detection and Treatment of Esophageal Injury After Catheter Ablation for Atrial Fibrillation
Recruitment status was: Recruiting
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Early Detection and Treatment of Esophageal Injury After Catheter Ablation for Atrial Fibrillation|
- Incidence of esophageal injury as assessed by endoscopy [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2007|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584922
|United States, Oklahoma|
|OU Medical Center|
|Oklahoma City, Oklahoma, United States, 73104|
|Principal Investigator:||Karen Beckman, MD||University of Oklahoma|