A Phase 3 interventional study of Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON] and Lumason in Heart Diseases, sponsored by Bracco Diagnostics, Inc. Recruiting at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-05.
Sponsored by Bracco Diagnostics, Inc · Phase 3, Interventional, and Diagnostic
A phase III study designed as a randomized, within-patient comparison of continuous infusion of diluted Lumason® versus the bolus administration of undiluted Lumason® for degree of LVO and assessment of LV EBD (co-primary endpoints).
This is a phase III study designed as a randomized, within-patient comparison of continuous infusion of diluted Lumason® versus the bolus administration of undiluted Lumason® for degree of LVO and assessment of LV EBD (co-primary endpoints). The study will enroll patients with suboptimal LV EBD defined as ≥2 adjacent segments in any apical view that cannot be visualized at pre-contrast echocardiogram.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's planned enrollment of 106 is close to the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →Bracco Diagnostics, Inc is the lead sponsor of 48 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Bolus administration of 2 mL undiluted Lumason®
Drug: Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]
Continuous infusion of 8 mL of diluted Lumason®
Drug: Lumason
Bolus administration of 2 mL undiluted Lumason®, to be administered in 20 seconds
Also known as: Bolus Administration
Continuous infusion of 8 mL of diluted Lumason® (4 mL of Lumason® diluted in 4 mL of saline) at a rate of 1.0 mL/min
Also known as: Infusion Administration
Adequate LV EBD Score
Compare the proportion of patients with adequate LV EBD score for infusion vs. bolus administrations in patients with suboptimal left ventricular endocardial border delineation at unenhanced echocardiography.
Time frame: 2-3 Hours
Adequate LV Opacification
Compare the proportion of patients with adequate LV opacification for infusion vs. bolus administrations in patients with suboptimal left ventricular endocardial border delineation at unenhanced echocardiography.
Time frame: 2-3 Hours
Clinically useful LVO
To compare the duration of clinically useful LVO in infusion vs. bolus administrations in terms of duration
Time frame: 2-3 Hours
Adverse events
Compare adverse event rate after infusion vs. bolus administrations
Time frame: 24 Hours
Plan to share: No
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Bracco Diagnostics, Inc