Heart Disease Clinical Trial
Official title:
A Multicenter Clinical Evaluation of Safety and Efficacy of Lumason as a Contrast Agent in Pediatric Echocardiography
Safety and Efficacy Study in pediatric subjects aged 9 to 17 years of age with suboptimal LV EBD on non-contrast 2D echocardiography. Imaging modalities that are used throughout the study in pediatric subjects represented those utilized in routine clinical practice in adults.
This was a Phase III, multicenter, open-label study that was to 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. It was estimated that 92 patients were
to be enrolled to provide 73 evaluable patients.
Three cardiologists unaffiliated with enrolling centers (blinded readers), blinded to the
patient's identity and clinical profile were to independently evaluate the echocardiograms.
The efficacy analysis was primarily based on the blinded reader evaluations.
Imaging modalities that are used throughout the study in pediatric subjects represented those
utilized in routine clinical practice in adults.
One of the sites participating in this study was to be asked 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 was designed to assess the efficacy of Lumason-enhanced echocardiography in
pediatric patients.
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