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

NCT ID: NCT00625365

Last Updated: 2020-11-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1060 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-07-31

Brief Summary

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

Detailed Description

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Conditions

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Cardiovascular Disease

Keywords

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DEFINITY Safety Survelliance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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DEFINITY® (Perflutren Lipid Microsphere)

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

Group Type OTHER

DEFINITY®

Intervention Type DRUG

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

Interventions

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DEFINITY®

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

Intervention Type DRUG

Other Intervention Names

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DEFINITY Perflutren Lipid Microsphere injectable suspension

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lantheus Medical Imaging

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Veronica Lee, MD

Role: STUDY_DIRECTOR

Lantheus Medical Imaging

Locations

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UCSD Medical Center

San Diego, California, United States

Site Status

Alfieri Cardiology

Newark, Delaware, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Maine Research Associates

Auburn, Maine, United States

Site Status

Park Nicolett Institute

Saint Louis Park, Minnesota, United States

Site Status

Cardiovascular Consultants, P.C.

Kansas City, Missouri, United States

Site Status

St. Louis University

St Louis, Missouri, United States

Site Status

St. Luke's-Roosevelt Hospital

New York, New York, United States

Site Status

Mt Sinai Medical Center

New York, New York, United States

Site Status

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

Site Status

Meritcare Heart Center Cardiology

Fargo, North Dakota, United States

Site Status

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

York Hospital

York, Pennsylvania, United States

Site Status

Consultants in Cardiology

Fort Worth, Texas, United States

Site Status

University of Texas Medical Center

Galveston, Texas, United States

Site Status

The Methodist DeBakey Heart Center

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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DMP 115-415

Identifier Type: -

Identifier Source: org_study_id