Detection of Left Atrial Appendage (LAA) Thrombus: Comparison of Cardiac Magnetic Resonance Imaging and Transesophageal Echocardiogram
Recruitment status was Recruiting
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.
Left Atrial Appendage Thrombi
|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|
- 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 ]
|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)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00797576
|Contact: Raju G Ailiani, MDfirstname.lastname@example.org|
|United States, Wisconsin|
|Gundersen Lutheran Health System||Recruiting|
|La Crosse, Wisconsin, United States, 54601|
|Contact: Vicki L McHugh, MS 608-775-3857 email@example.com|
|Contact: Kara J Kallies, BA 608-775-2904 firstname.lastname@example.org|
|Principal Investigator: Raju G Ailiani, MD|
|Principal Investigator:||Raju G Ailiani, MD||Gundersen Lutheran Health System|
|Study Director:||Vicki L McHugh, MS||Gundersen Lutheran Medical Foundation|