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Trial Using Impella LP 2.5 System in Patients With Acute Myocardial Infarction Induced Hemodynamic Instability (RECOVER II)

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ClinicalTrials.gov Identifier: NCT00972270
Recruitment Status : Terminated (Study closed due to insufficient enrollment)
First Posted : September 4, 2009
Last Update Posted : March 21, 2011
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Device: Impella LP 2.5 Device: Intra-Aortic Balloon Pump Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RECOVER II Trial: A Prospective Randomized Trial Investigating the Use of the IMPELLA RECOVER LP 2.5 System in Patients With Acute Myocardial Infarction Induced Hemodynamic Instability
Study Start Date : July 2008
Primary Completion Date : August 2010
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: IMPELLA LP 2.5 Device: 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.
Active Comparator: Intra-Aortic Balloon Pump Device: Intra-Aortic Balloon Pump
The Intra-Aortic Balloon Pump consists of a cylindrical balloon that sits in the aorta and counterpulsates.

Outcome Measures

Primary Outcome Measures :
  1. Composite rate of major adverse events within 30 days or hospital discharge. [ Time Frame: 30 days or discharge ]
    Composite rate of major adverse events within 30 days or hospital discharge.

Secondary Outcome Measures :
  1. Maximum CPO increase from baseline. [ Time Frame: Treatment ]
    Maximum CPO increase from baseline.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00972270

United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Kansas
Shawnee Mission
Shawnee Mission, Kansas, United States, 66204
United States, New Jersey
Valley Hospital
Hawthorne, New Jersey, United States, 07506
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Riverside Methodist
Columbus, Ohio, United States, 43214
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Pinnacle Health
Wormleysburg, Pennsylvania, United States, 17043
York Hospital
York, Pennsylvania, United States, 17403
United States, Texas
Methodist Hospital
Houston, Texas, United States, 77030
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84157
Sponsors and Collaborators
Abiomed Inc.
Principal Investigator: William O'Neill, M.D. Not affiliated with Abiomed
More Information

Responsible Party: Karim Benali, MD/ Chief Medical Officer, Abiomed
ClinicalTrials.gov Identifier: NCT00972270     History of Changes
Other Study ID Numbers: IDE: G080021
First Posted: September 4, 2009    Key Record Dates
Last Update Posted: March 21, 2011
Last Verified: March 2011

Keywords provided by Abiomed Inc.:
Arterial Occlusive Disease
Heart Diseases
Myocardial Ischemia
Vascular Disease

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases