Phase 4 N=100 Diagnostic

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

Atrial Fibrillation

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View on ClinicalTrials.gov: NCT01721447 ↗

Enrolled (actual)

100

Serious AEs

1.0%

Results posted

Jun 2019

Primary outcome: Primary: Percent Confidence in Assessment of Left Atrial Appendage Thrombus — 55; 95 Percentage of Confidence — p=< 0.001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Optison echocardiography contrast agent (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Utah
Primary completion: May 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Confidence in Assessment of Left Atrial Appendage Thrombus	55; 95	< 0.001 sig
SECONDARY Concordance Between Echo Readers in Determining Presence or Absence of Thrombus in the Left Atrial Appendage	72; 96	< 0.001 sig

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01721447). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.