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

Lantheus Medical Imaging1,060 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

1,060

Conditions

Cardiovascular Disease

Interventions

DEFINITY®DRUG

DEFINITY may be injected by either an intravenous or bolus injection or infusion. Dosage as per standard clinical practice and Package Insert

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (16)

UCSD Medical Center

San Diego, California, United States

Alfieri Cardiology

Newark, Delaware, United States

Outcomes

Primary Outcomes

The Number and Percentage of Patients With Death or Life Threatening Cardiopulmonary Events Occurring Following Definity Administration

Time frame: during or within 30 minutes of administration

Secondary Outcomes

Serious Adverse Events

Summary of the number and percentage of participants with serious adverse events occuring following completion of DEFINITY administration

Time frame: Through 24 hours

Adverse Events

Summary of the number and percentage of participants with adverse events occuring following completion of DEFINITY administration

Time frame: Through 24 hours

Data from ClinicalTrials.gov

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