NCT00650728

Brief Summary

As the left atrium is in close vicinity to the esophagus, radiofrequency ablation in the left atrium may damage the esophagus and create esophageal perforations and esophageal left atrial fistula. The aim of the present study is to compare different methods for visualization of the esophagus to prevent this complication.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Mar 2008

Shorter than P25 for not_applicable atrial-fibrillation

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

March 1, 2008

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 2, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

June 27, 2011

Status Verified

June 1, 2011

Enrollment Period

1.2 years

First QC Date

March 28, 2008

Last Update Submit

June 22, 2011

Conditions

Atrial Fibrillation

Keywords

radiofrequency ablation

Outcome Measures

Primary Outcomes (1)

  • Accuracy of localization of the esophagus in relation to the left atrium

    one year

Interventions

placing gastric tubePROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with atrial fibrillation undergoing radiofrequency ablation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Luzern, Department of Cardiology

Lucerne, Canton of Lucerne, 6005, Switzerland

Location

Related Publications (1)

  • Kobza R, Schoenenberger AW, Erne P. Esophagus imaging for catheter ablation of atrial fibrillation: comparison of two methods with showing of esophageal movement. J Interv Card Electrophysiol. 2009 Dec;26(3):159-64. doi: 10.1007/s10840-009-9434-3. Epub 2009 Sep 10.

    PMID: 19757002BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Paul Erne

    Luzerner Kantonsspital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 28, 2008

First Posted

April 2, 2008

Study Start

March 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

June 27, 2011

Record last verified: 2011-06

Locations

CH(1)