Trial Using Impella LP 2.5 System in Patients With Acute Myocardial Infarction Induced Hemodynamic Instability
NCT ID: NCT00972270
Last Updated: 2011-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
1 participants
INTERVENTIONAL
2008-07-31
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IMPELLA LP 2.5
Impella LP 2.5
Insertion of the LP 2.5 IMPELLA circulatory support system that can be placed across the aortic valve using a single femoral site. The device pumps blood from the left ventricle into the ascending aorta at 2.5L/min.
Intra-Aortic Balloon Pump
Intra-Aortic Balloon Pump
The Intra-Aortic Balloon Pump consists of a cylindrical balloon that sits in the aorta and counterpulsates.
Interventions
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Impella LP 2.5
Insertion of the LP 2.5 IMPELLA circulatory support system that can be placed across the aortic valve using a single femoral site. The device pumps blood from the left ventricle into the ascending aorta at 2.5L/min.
Intra-Aortic Balloon Pump
The Intra-Aortic Balloon Pump consists of a cylindrical balloon that sits in the aorta and counterpulsates.
Eligibility Criteria
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Inclusion Criteria
* Subject presenting with STEMI undergoing primary PCI
* Patient presents with at least 1 of the following:
* Unstable blood pressure
* Tachycardia and tissue hypoperfusion
* The need for intravenous pressor or inotropic support
* Patient presents with STEMI:
* CK-MB\>2x normal
Exclusion Criteria
* Abnormalities of the aorta
* Recent stroke or TIA
* Mural thrombus in the left ventricle
18 Years
90 Years
ALL
No
Sponsors
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Abiomed Inc.
INDUSTRY
Responsible Party
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Abiomed
Principal Investigators
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William O'Neill, M.D.
Role: PRINCIPAL_INVESTIGATOR
Not affiliated with Abiomed
Locations
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Hartford Hospital
Hartford, Connecticut, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Shawnee Mission
Shawnee Mission, Kansas, United States
Valley Hospital
Hawthorne, New Jersey, United States
Ohio State University
Columbus, Ohio, United States
Riverside Methodist
Columbus, Ohio, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Pinnacle Health
Wormleysburg, Pennsylvania, United States
York Hospital
York, Pennsylvania, United States
Methodist Hospital
Houston, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
Countries
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Other Identifiers
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IDE: G080021
Identifier Type: -
Identifier Source: org_study_id
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