Overview
A Prospective, Phase IV, Surveillance Registry Study to Evaluate the Safety of DEFINITY® in Clinical Practice
Status:
Completed
Completed
Trial end date:
2009-07-01
2009-07-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this registry study is to gather safety information on the current clinical use of and the safety of DEFINITY®Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Lantheus Medical Imaging
Criteria
Inclusion criteria- Patients who, in the investigator's opinion, require DEFINITY® echocardiography due to
suboptimal, unenhanced images.
Exclusion criteria
- Known hypersensitivity to perflutren, DEFINITY®, or other echo contrast agent.
- Prior SAE associated with perflutren, DEFINITY®, or administration of other echo
contrast agent.