Early Detection and Treatment of Esophageal Injury After Catheter Ablation for Atrial Fibrillation

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Endoscopy in group I (all patients)

• Registration Number: NCT00584922
• Lead Sponsor: University of Oklahoma

Brief Summary

The purpose of this study is to prospectively follow the next 200 patients who undergo catheter ablation of atrial fibrillation for symptoms and signs of esophageal injury.

Detailed Description

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:

1. Assess the incidence of visible transmural esophageal injury following extensive ablation in the posterior left atrium as measured by endoscopy1

2. Assess whether early detection of esophageal injury by endoscopy and treatment will prevent development of more serious injury such as left atrial-esophageal fistula

3. 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 Timeline

• Study Start: 2006-12-05
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-31
• Study First Posted: 2008-01-02
• Primary Completion: 2011-03-11
• Study Completion: 2011-12
• Results First Submitted: 2017-03-22
• Status Verified: 2019-05
• Results First Submitted QC: 2019-05-07
• Last Update Submitted: 2019-05-07
• Results First Posted: 2019-07-15
• Last Update Posted: 2019-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

• 18-80 years
• Scheduled to have catheter ablation of atrial fibrillation or left atrial macroreentrant tachycardia.

Exclusion Criteria

• Contraindication to endoscopy
• Pregnancy
• Prisoners
• Inability or unwillingness to give informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AF ablation group	Endoscopy in group I (all patients)	Patients undergoing catheter ablation of atrial fibrillation or left atrial macroreentrant tachycardia.

Primary Outcome Measures

Name	Time	Method
Incidence of Esophageal Injury as Assessed by Endoscopy	1 month	Endoscopy results and clinical status at one month after endoscopy procedure.

Trial Locations

Locations (1)

OU Medical Center; 🇺🇸 Oklahoma City, Oklahoma, United States