Efficacy of Optison Echo Contrast to Detect Thrombus in Left Atrial Appendage "DOLOP"

Recruiting

Phase 4 Results N/A

Trial Description

The investigators intend to determine if using Optison echocardiography contrast increases sensitivity and specificity of detecting left atrial appendage thrombus in transesophageal echocardiography studies as opposed to standard 2D and 3D TEE imaging without the use of echo contrast.

Detailed Description

Accurate determination of the presence or absence of left atrial appendage (LAA) thrombus has a large impact on the clinical course of patients with atrial fibrillation or ischemic stroke and has large financial implications as well. Misdiagnosing the presence of LAA thrombus can lead to unnecessarily cancelled procedures (cardioversion and atrial fibrillation ablation) and potentially hazardous, unnecessary changes in clinical care (such as prolonged Coumadin anticoagulation). Missing LAA thrombus can result in continuation of cardioversion or atrial fibrillation ablation procedures at a time when there is higher risk of subsequent embolic stroke.
Several of the patients with atrial fibrillation require transesophageal echocardiography (TEE) performed prior to cardioversion or atrial fibrillation ablation procedures. There is opportunity to enroll most of these patients in our proposed study. There has been essentially no work published about the use of echo contrast materials in TEE (other than agitated saline), particularly the use of Optison. Thus, the investigators will be exploring a new field in echocardiography and echo contrast.

Conditions

Interventions

  • Optison echocardiography contrast agent Drug
    Other Names: Perflutren Protein-Type A microspheres
    Intervention Desc: Subjects undergoing transesophageal echocardiography who will receive the Optison contrast agent during the procedure to test if the image quality improves to provide accurate assessment of the presence of left atrial thrombus.
    ARM 1: Kind: Experimental
    Label: Echo arm
    Description: Subjects with atrial fibrillation who are undergoing a transesophageal echocardiography procedure for deciding treatment regimen

Trial Design

  • Masking: Open Label
  • Purpose: Diagnostic
  • Endpoint: Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Sensitivity of TEE to identify thrombus in left atrium one Transesophageal Echocardiography No
Secondary Specificity of TEE to detect left atrial thrombus One transesophageal echocardiography No

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