Status:
COMPLETED
A Prospective, Phase IV, Surveillance Registry Study to Evaluate the Safety of DEFINITY® in Clinical Practice
Lead Sponsor:
Lantheus Medical Imaging
Conditions:
Cardiovascular Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this registry study is to gather safety information on the current clinical use of and the safety of DEFINITY®
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
1060 Patients enrolled
Trial Details
Trial ID
NCT00625365
Start Date
February 1 2008
End Date
July 1 2009
Last Update
November 24 2020
Active Locations (16)
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1
UCSD Medical Center
San Diego, California, United States, 92103-8411
2
Alfieri Cardiology
Newark, Delaware, United States, 19713
3
Northwestern University
Chicago, Illinois, United States, 60611-2969
4
Maine Research Associates
Auburn, Maine, United States, 04210