NCT00584922

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 5, 2006

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 2, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
7.6 years until next milestone

Results Posted

Study results publicly available

July 15, 2019

Completed
Last Updated

July 15, 2019

Status Verified

May 1, 2019

Enrollment Period

4.3 years

First QC Date

December 20, 2007

Results QC Date

March 22, 2017

Last Update Submit

May 7, 2019

Conditions

Atrial Fibrillation

Keywords

Esophageal injuryCatheter AblationAtrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Incidence of Esophageal Injury as Assessed by Endoscopy

    Endoscopy results and clinical status at one month after endoscopy procedure.

    1 month

Study Arms (1)

AF ablation group

Patients undergoing catheter ablation of atrial fibrillation or left atrial macroreentrant tachycardia.

Procedure: Endoscopy in group I (all patients)

Interventions

Endoscopy in group I (all patients)PROCEDURE

Post procedure endoscopy, omeprazole 40 mg BID, sucralfate 1 gm BID for 2-4 weeks.

AF ablation group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • years
  • Scheduled to have catheter ablation of atrial fibrillation or left atrial macroreentrant tachycardia.

You may not qualify if:

  • Contraindication to endoscopy
  • Pregnancy
  • Prisoners
  • Inability or unwillingness to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OU Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Results Point of Contact

Title
Sunny Po, MD, PhD
Organization
University of Oklahoma Health Science Center
Sunny-Po@ouhsc.edu
405-271-9696

Study Officials

  • Karen Beckman, MD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2007

First Posted

January 2, 2008

Study Start

December 5, 2006

Primary Completion

March 11, 2011

Study Completion

December 1, 2011

Last Updated

July 15, 2019

Results First Posted

July 15, 2019

Record last verified: 2019-05

Locations

US(1)