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

NCT ID: NCT00584922

Last Updated: 2019-07-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 175 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-12-05
• Study Completion Date: 2011-12-31

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.

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

AF ablation group

Patients undergoing catheter ablation of atrial fibrillation or left atrial macroreentrant tachycardia.

Endoscopy in group I (all patients)

Intervention Type: PROCEDURE

Post procedure endoscopy, omeprazole 40 mg BID, sucralfate 1 gm BID for 2-4 weeks.

Interventions

Endoscopy in group I (all patients)

Post procedure endoscopy, omeprazole 40 mg BID, sucralfate 1 gm BID for 2-4 weeks.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen Beckman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

OU Medical Center

Oklahoma City, Oklahoma, United States

Countries

United States

Other Identifiers

13165

Identifier Type: -

Identifier Source: org_study_id