Evaluation of Safety and Efficacy of Lumason in Pediatric Echocardiography

This is a Phase III, multicenter, open-label study that will be conducted at approximately
7-12 sites in the United States, Canada and Europe in pediatric patients with suboptimal LV
EBD on non-contrast 2D transthoracic echocardiography with harmonic imaging. It is estimated
that 92 patients will be enrolled to provide 73 evaluable patients.

Three cardiologists unaffiliated with enrolling centers (blinded readers), blinded to the
patient's identity and clinical profile will independently evaluate the echocardiograms. The
efficacy analysis will be primarily based on the blinded reader evaluations.

Imaging conditions will be representative of those used in routine clinical practice and will
include LV EBD with harmonic imaging modality.

One of the sites participating in this study will also be requested to consent a subset of
patients for additional blood sampling for analysis of SF6 concentration in blood from a
total of 6 patients (3 males and 3 females) in the age group 9 up to 12 years of age and 6
patients (3 males and 3 females) in the age of >12 up to and including 17 years.

The current study is designed to assess the efficacy of Lumason-enhanced

Inclusion Criteria:

- Provide Written informed consent from parent(s) or legal guardian

- Provide assent when required according to local regulations

- Suspected of having cardiac disease or undergoing evaluation of cardiac anatomy for
congenital heart disease

- Undergone a previous transthoracic echocardiogram within one month prior to enrollment
resulting in suboptimal Left ventricular endocardial border definition as ≥ 2
contiguous segments in any given view that cannot be visualized.

Exclusion Criteria:

- Children < 9 years of age

- Previously enrolled in the study

- Administered any other contrast agent either intravascularly or orally within 48 hours
of Lumason administration

- Known right-to-left, bidirectional or transient cardiac shunt( ruled out with agitated
saline study performed before administration of Lumason

- Known hypersensitivity to one or more of the ingredients of the investigational
product

- Received an investigational compound within 30 days before enrolling into this study

- Pregnant or lactating female

- Determined by investigator to be unsuitable for the study