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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00584922
• Other study ID #: 13165
• Status: Completed
• Start date: December 5, 2006
• Est. completion date: December 2011

Study information

• Verified date: May 2019
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: December 2011
• Est. primary completion date: March 11, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Endoscopy in group I (all patients)
Post procedure endoscopy, omeprazole 40 mg BID, sucralfate 1 gm BID for 2-4 weeks.

Locations

Country	Name	City	State
United States	OU Medical Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Esophageal Injury as Assessed by Endoscopy	Endoscopy results and clinical status at one month after endoscopy procedure.	1 month