Detection of Left Atrial Appendage Thrombus in Patients Referred For Cardioversion: Comparative Analysis of Cardiac Magnetic Resonance Imaging and Transesophageal Echocardiogram

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

Sponsors

Lead sponsor: Gundersen Lutheran Medical Foundation

Collaborator: Gundersen Lutheran Health System

Source 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.

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.

Overall Status Unknown status
Start Date June 2008
Completion Date July 2010
Primary Completion Date June 2010
Study Type Observational
Primary Outcome
Measure Time Frame
Accuracy values for CMR Imaging for detection of LAA thrombus. (sensitivity, specificity, negative predictive value, and positive predictive value) 24 hours
Enrollment 25
Condition
Eligibility

Sampling method: Non-Probability Sample

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

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Overall Contact

Last name: Raju G Ailiani, MD

Phone: 608-775-2595

Email: [email protected]

Location
facility status contact contact_backup investigator Gundersen Lutheran Health System Vicki L McHugh, MS 608-775-3857 [email protected] Raju G Ailiani, MD Principal Investigator
Location Countries

United States

Verification Date

August 2009

Responsible Party

Name title: Raju G Ailiani, MD

Organization: Gundersen Lutheran Helath system

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: 1/Cases

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

Arm group label: 2/Controls

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

Study Design Info

Observational model: Case Control

Time perspective: Prospective

Source: ClinicalTrials.gov