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

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-09-30

Brief Summary

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This is a randomized trial investigating the use of the IMPELLA RECOVER LP 2.5 compared to Intra-aortic balloon pump (IABP) in patients with Acute Myocardial Infarction.

Detailed Description

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Conditions

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Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IMPELLA LP 2.5

Group Type EXPERIMENTAL

Impella LP 2.5

Intervention Type DEVICE

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

Group Type ACTIVE_COMPARATOR

Intra-Aortic Balloon Pump

Intervention Type DEVICE

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.

Intervention Type DEVICE

Intra-Aortic Balloon Pump

The Intra-Aortic Balloon Pump consists of a cylindrical balloon that sits in the aorta and counterpulsates.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Informed Consent
* 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

* Unwitnessed cardiac arrest
* Abnormalities of the aorta
* Recent stroke or TIA
* Mural thrombus in the left ventricle
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abiomed Inc.

INDUSTRY

Sponsor Role lead

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

Site Status

University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

Shawnee Mission

Shawnee Mission, Kansas, United States

Site Status

Valley Hospital

Hawthorne, New Jersey, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

Riverside Methodist

Columbus, Ohio, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Pinnacle Health

Wormleysburg, Pennsylvania, United States

Site Status

York Hospital

York, Pennsylvania, United States

Site Status

Methodist Hospital

Houston, Texas, United States

Site Status

Intermountain Medical Center

Murray, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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IDE: G080021

Identifier Type: -

Identifier Source: org_study_id

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