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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. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by University of Oklahoma.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00584922
First Posted: January 2, 2008
Last Update Posted: March 3, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Oklahoma
  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:


Further study details as provided by University of Oklahoma:

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

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 Submitted: December 20, 2007
First Posted: January 2, 2008
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


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