Status:

TERMINATED

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

Lead Sponsor:

Abiomed Inc.

Conditions:

Acute Myocardial Infarction

Eligibility:

All Genders

18-90 years

Phase:

PHASE3

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.

Eligibility Criteria

Inclusion

  • 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

  • Unwitnessed cardiac arrest
  • Abnormalities of the aorta
  • Recent stroke or TIA
  • Mural thrombus in the left ventricle

Key Trial Info

Start Date :

July 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2010

Estimated Enrollment :

1 Patients enrolled

Trial Details

Trial ID

NCT00972270

Start Date

July 1 2008

End Date

September 1 2010

Last Update

March 21 2011

Active Locations (11)

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Page 1 of 3 (11 locations)

1

Hartford Hospital

Hartford, Connecticut, United States, 06102

2

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

3

Shawnee Mission

Shawnee Mission, Kansas, United States, 66204

4

Valley Hospital

Hawthorne, New Jersey, United States, 07506