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

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ClinicalTrials.gov Identifier: NCT00584922
Recruitment Status : Unknown
Verified March 2011 by University of Oklahoma.
Recruitment status was:  Recruiting
First Posted : January 2, 2008
Last Update Posted : March 3, 2011
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment
Atrial Fibrillation Procedure: Endoscopy in group I (all patients)

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 Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Detection and Treatment of Esophageal Injury After Catheter Ablation for Atrial Fibrillation
Study Start Date : January 2007
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
1
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.



Primary Outcome Measures :
  1. Incidence of esophageal injury as assessed by endoscopy [ Time Frame: 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients 18-80 scheduled to undergo catheter ablation of atrial fibrillation
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00584922


Contacts
Contact: Karen Beckman, MD 405-271-9696 ext 37536 Karen-Beckman@ouhsc.edu

Locations
United States, Oklahoma
OU Medical Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Principal Investigator: Karen Beckman, MD         
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Karen Beckman, MD University of Oklahoma

Responsible Party: Sunny Po, M.D., PhD., University of Oklahoma Health Sciences Center
ClinicalTrials.gov Identifier: NCT00584922     History of Changes
Other Study ID Numbers: 13165
First Posted: January 2, 2008    Key Record Dates
Last Update Posted: March 3, 2011
Last Verified: March 2011

Keywords provided by University of Oklahoma:
Esophageal injury
Catheter Ablation
Atrial Fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes