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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Gundersen Lutheran Medical Foundation.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Gundersen Lutheran Health System
Information provided by:
Gundersen Lutheran Medical Foundation
ClinicalTrials.gov Identifier:
NCT00797576
First received: November 24, 2008
Last updated: June 21, 2010
Last verified: August 2009
History of Changes
  Purpose

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
Left Atrial Appendage Thrombi

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gundersen Lutheran Medical Foundation:

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

Estimated Enrollment: 25
Study Start Date: June 2008
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00797576

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

Locations
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
Investigators
Principal Investigator: Raju G Ailiani, MD Gundersen Lutheran Health System
Study Director: Vicki L McHugh, MS Gundersen Lutheran Medical Foundation
  More Information

Publications:
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
Study First Received: November 24, 2008
Last Updated: June 21, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on June 18, 2013