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

May 7, 2019 updated by: University of Oklahoma
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

175

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • OU Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients 18-80 scheduled to undergo catheter ablation of atrial fibrillation

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AF ablation group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Esophageal Injury as Assessed by Endoscopy
Time Frame: 1 month
Endoscopy results and clinical status at one month after endoscopy procedure.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Investigators

  • Principal Investigator: Karen Beckman, MD, University of Oklahoma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2006

Primary Completion (Actual)

March 11, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

December 20, 2007

First Submitted That Met QC Criteria

December 31, 2007

First Posted (Estimate)

January 2, 2008

Study Record Updates

Last Update Posted (Actual)

July 15, 2019

Last Update Submitted That Met QC Criteria

May 7, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13165

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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