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

Utah System of Higher Education (USHE)

Status and phase: Completed; Phase 4

Conditions: Atrial Fibrillation

Treatments: Drug: Optison echocardiography contrast agent

Study type: Interventional

Funder types: Other

Identifiers

NCT01721447

11-OPT-018 GE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• > 18 years old
• Cognitively sound and able to provide informed consent
• Indicated for TEE as a standard clinical procedure for evaluation of cardiac health status.

Exclusion criteria

• Contraindicated for Optison administration
• Known right-to-left or bi-directional cardiac shunts
• Hypersensitivity to perflutren, blood, blood products or albumen
• Women who are pregnant
• Removal of Left Atrial Appendage
• Not able to provide informed consent

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Echo arm

Experimental group

Description:

Subjects with atrial fibrillation who are undergoing a TEE procedure will be assessed using Optison echocardiography contrast agent

Treatment:

Drug: Optison echocardiography contrast agent