A Prospective, Phase IV, Surveillance Registry Study to Evaluate the Safety of DEFINITY® in Clinical Practice

Lantheus Medical Imaging

Status and phase: Completed; Phase 4

Conditions: Cardiovascular Disease

Treatments: Drug: DEFINITY®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00625365

DMP 115-415

Details and patient eligibility

About

The purpose of this registry study is to gather safety information on the current clinical use of and the safety of DEFINITY®

Enrollment: 1,060 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,060 participants in 1 patient group

DEFINITY® (Perflutren Lipid Microsphere)

Other group

Description:

Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography

Treatment:

Drug: DEFINITY®