Early Detection and Treatment of Esophageal Injury After Catheter Ablation for Atrial Fibrillation - Full Text View

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)

Genetics Home Reference related topics:

Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics:

Endoscopy Esophagus Disorders

Drug Information available for:

Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	200
Study Start Date:	January 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (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, sulcrafate 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 sucrafate 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:

Assess the incidence of visible transmural esophageal injury following extensive ablation in the posterior left atrium as measured by endoscopy1
Assess whether early detection of esophageal injury by endoscopy and treatment will prevent development of more serious injury such as left atrial-esophageal fistula
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

Responsible Party:	University of Oklahoma Health Sciences Center ( Karen Beckman )
Study ID Numbers:	13165
First Received:	December 20, 2007
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00584922
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Oklahoma:

Esophageal injury

Catheter Ablation

Atrial Fibrillation

Study placed in the following topic categories:

Heart Diseases

Esophageal disorder

Omeprazole

Atrial Fibrillation

Esophageal Diseases

Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 28, 2008

Sponsored by:	University of Oklahoma
Information provided by:	University of Oklahoma
ClinicalTrials.gov Identifier:	NCT00584922