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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
  Purpose

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 Intervention
Atrial Fibrillation
 Procedure: Endoscopy in group I (all patients)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Detection and Treatment of Esophageal Injury After Catheter Ablation for Atrial Fibrillation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Incidence of esophageal injury as assessed by endoscopy [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: January 2007
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: December 20, 2007
Last Updated: March 2, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Atrial Fibrillation
Esophageal Diseases
Arrhythmias, Cardiac
Heart Diseases
 Cardiovascular Diseases
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013