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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of Oklahoma.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00584922
First received: December 20, 2007
Last updated: March 2, 2011
Last verified: March 2011
History of Changes

December 20, 2007
March 2, 2011
January 2007
December 2011   (final data collection date for primary outcome measure)
Incidence of esophageal injury as assessed by endoscopy [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00584922 on ClinicalTrials.gov Archive Site
Not Provided
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Early Detection and Treatment of Esophageal Injury After Catheter Ablation for Atrial Fibrillation
Early Detection and Treatment of Esophageal Injury After Catheter Ablation for Atrial Fibrillation

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients 18-80 scheduled to undergo catheter ablation of atrial fibrillation
Atrial Fibrillation
Procedure: Endoscopy in group I (all patients)
Post procedure endoscopy, omeprazole 40 mg BID, sucralfate 1 gm BID for 2-4 weeks.
1
Patients undergoing catheter ablation of atrial fibrillation or left atrial macroreentrant tachycardia.
Intervention: Procedure: Endoscopy in group I (all patients)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Karen Beckman, MD 405-271-9696 ext 37536 Karen-Beckman@ouhsc.edu
United States
 
NCT00584922
13165
No
Sunny Po, M.D., PhD., University of Oklahoma Health Sciences Center
University of Oklahoma
Not Provided
Principal Investigator: Karen Beckman, MD University of Oklahoma
University of Oklahoma
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP