Conditions: Echocardiography
Keywords: Surveillance Optison Perflutren Echocardiography Subjects receive Optison during enhanced echocardiography
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 1039
Healthy volunteers: no

Brief summary:
This prospective surveillance trial will gather safety information for Optison when it is used in routine practice.

Detailed description:

Arms:
arm 1: Open Label

Interventions: intervention 1: Perflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP)
Intervention descriptions: intervention 1: The recommended dose of Optison is 0.5mL injected into a peripheral vein. This may be repeated for further contrast enhancement as needed.

The injection rate should not exceed 1mL per second. Follow the Optison injection with a flush of 0.9% sodium chloride injection, USP or 5% dextrose in water injection, United States Pharmacopeia (USP) .

The maximum total dose should not exceed 5.0mL in any 10 minutes period. The maximum total dose should not exceed 8.7mL in any one patient study.

Protocol document: