Recruiting

Cardiac Imaging

Sponsor:

Gundersen Lutheran Medical Foundation

Code:

NCT00797576

Conditions

Left Atrial Appendage Thrombi

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Study Details

Brief summary:

The purpose of this study is to compare Cardiac Magnetic Resonance (CMR) Imaging with transesophageal echocardiography (TEE) in detecting the presence of LAA thrombi in men and women with atrial fibrillation presenting for cardioversion.

Conditions

Left Atrial Appendage Thrombi

Study ID

NCT00797576

Start date

Jun, 2008

Status verified date

Aug, 2009

Completion date

Jul, 2010

Anticipated

Primary completion date

Jun, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • atrial fibrillation

Exclusion Criteria:

  • ICDs
  • pacemakers
  • intracranial clips
  • intracranial stimulator devices
  • insulin pumps
  • intra ocular metal foreign bodies
  • cochlear implants
  • LAA amputation as part of CABG and/or valve surgery
  • GFR < 60 mL/min

Study Design

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Arms

1/Cases

Subjects whom had cardioversion aborted due to LAA thrombus or suspicion of LAA thrombus on TEE.

2/Controls

Subjects with underlying atrial fibrillation undergoing elective TEE as clinically indicated for any reason.

Primary outcome measure

  • Accuracy values for CMR Imaging for detection of LAA thrombus. (sensitivity, specificity, negative predictive value, and positive predictive value) [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Raju G Ailiani, MD

608-775-2595rgailian@gundluth.org

Locations

Gundersen Lutheran Health System

Recruiting

La Crosse, Wisconsin, United States, 54601

Contacts

Vicki L McHugh, MS

608-775-3857vlmchugh@gundluth.org

Kara J Kallies, BA

608-775-2904kjkallie@gundluth.org

Principal Investigator:

Raju G Ailiani, MD

More Information

Sponsor

Gundersen Lutheran Medical Foundation

Last update posted

Jun 22, 2010

Last verified

Aug, 2009

Keywords

  • left atrial appendage thrombi
  • transesophageal echocardiogram
  • cardiac magnetic resonance imaging
  • atrial fibrillation
  • cardioversion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Gundersen Lutheran Medical Foundation on 2010-06-22.