Trial Using Impella LP 2.5 System in Patients With Acute Myocardial Infarction Induced Hemodynamic Instability

Phase 3

Terminated

• Conditions: Acute Myocardial Infarction
• Interventions: Device: Impella LP 2.5; Device: Intra-Aortic Balloon Pump

• Registration Number: NCT00972270
• Lead Sponsor: Abiomed Inc.

Brief Summary

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

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2009-09-02
• Study First Submitted QC: 2009-09-03
• Study First Posted: 2009-09-04
• Primary Completion: 2010-08
• Study Completion: 2010-09
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-18
• Last Update Posted: 2011-03-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMPELLA LP 2.5	Impella LP 2.5	-
Intra-Aortic Balloon Pump	Intra-Aortic Balloon Pump	-

Primary Outcome Measures

Name	Time	Method
Composite rate of major adverse events within 30 days or hospital discharge.	30 days or discharge	Composite rate of major adverse events within 30 days or hospital discharge.

Secondary Outcome Measures

Name	Time	Method
Maximum CPO increase from baseline.	Treatment	Maximum CPO increase from baseline.

Trial Locations

Locations (11)

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

York Hospital; 🇺🇸 York, Pennsylvania, United States

Valley Hospital; 🇺🇸 Hawthorne, New Jersey, United States

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States

Shawnee Mission; 🇺🇸 Shawnee Mission, Kansas, United States

Riverside Methodist; 🇺🇸 Columbus, Ohio, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Pinnacle Health; 🇺🇸 Wormleysburg, Pennsylvania, United States

Methodist Hospital; 🇺🇸 Houston, Texas, United States

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States