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Detection of Left Atrial Appendage (LAA) Thrombus: Comparison of Cardiac Magnetic Resonance Imaging and Transesophageal Echocardiogram

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ClinicalTrials.gov Identifier: NCT00797576
Recruitment Status : Unknown
Verified August 2009 by Gundersen Lutheran Medical Foundation.
Recruitment status was:  Recruiting
First Posted : November 25, 2008
Last Update Posted : June 22, 2010
Gundersen Lutheran Health System
Information provided by:
Gundersen Lutheran Medical Foundation

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.

Condition or disease
Left Atrial Appendage Thrombi

Detailed Description:
The identification of left atrial appendage (LAA) thrombus prior to cardioversion for patients with atrial fibrillation is crucial. LAA thrombus can be a frequent cause of cerebral stroke or peripheral embolism post cardioversion, and anticoagulation therapy is required in these instances to prevent cerebral events and avoid embolization. To date, TEE has been considered the clinical reference in detection of LAA thrombi with high diagnostic accuracy. However, diagnosis and size estimation of LAA thrombi remains challenging due to the complex anatomy of the LAA, and transesophageal echocardiography (TEE) is considered a semi-invasive procedure. To date, there have been few comparative studies involving TEE and cardiac magnetic resonance (CMR) imaging, and the results have been conflicting. With newer CMR Imaging techniques now available, we hypothesize that comparable results will be achieved in detecting LAA thrombus in subjects using a less invasive procedure.

Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Detection of Left Atrial Appendage Thrombus in Patients Referred For Cardioversion: Comparative Analysis of Cardiac Magnetic Resonance Imaging and Transesophageal Echocardiogram
Study Start Date : June 2008
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Subjects whom had cardioversion aborted due to LAA thrombus or suspicion of LAA thrombus on TEE.
Subjects with underlying atrial fibrillation undergoing elective TEE as clinically indicated for any reason.

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

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study cases will consist of subjects referred for TEE prior to cardioversion who are found to have LAA thrombus present. Control subjects will be patients referred for TEE with chronic atrial fibrillation that will not be undergoing cardioversion. All subjects will be patients from our facility, Gundersen Lutheran Health System, La Crosse, WI.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00797576

Contact: Raju G Ailiani, MD 608-775-2595 rgailian@gundluth.org

United States, Wisconsin
Gundersen Lutheran Health System Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Vicki L McHugh, MS    608-775-3857    vlmchugh@gundluth.org   
Contact: Kara J Kallies, BA    608-775-2904    kjkallie@gundluth.org   
Principal Investigator: Raju G Ailiani, MD         
Sponsors and Collaborators
Gundersen Lutheran Medical Foundation
Gundersen Lutheran Health System
Principal Investigator: Raju G Ailiani, MD Gundersen Lutheran Health System
Study Director: Vicki L McHugh, MS Gundersen Lutheran Medical Foundation

Saksena S, Sra JS, Jordaens L, et al. Intracardiac Echocardiography-Guided Cardioversion Helps Interventional Procedures (ICE-CHIP) trial. Heart Rhythm Society 2007 Scientific Sessions; May 11, 2007; Denver, CO. Late Breaking clinical Trials II.

Responsible Party: Raju G Ailiani, MD, Gundersen Lutheran Helath system
ClinicalTrials.gov Identifier: NCT00797576     History of Changes
Other Study ID Numbers: 2-07-05-001
First Posted: November 25, 2008    Key Record Dates
Last Update Posted: June 22, 2010
Last Verified: August 2009

Keywords provided by Gundersen Lutheran Medical Foundation:
left atrial appendage thrombi
transesophageal echocardiogram
cardiac magnetic resonance imaging
atrial fibrillation

Additional relevant MeSH terms:
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases