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

This study has been terminated.
(Study closed due to insufficient enrollment)
Sponsor:
Information provided by:
Abiomed Inc.
ClinicalTrials.gov Identifier:
NCT00972270
First received: September 2, 2009
Last updated: March 18, 2011
Last verified: March 2011
History of Changes

September 2, 2009
March 18, 2011
July 2008
August 2010   (final data collection date for primary outcome measure)
Composite rate of major adverse events within 30 days or hospital discharge. [ Time Frame: 30 days or discharge ] [ Designated as safety issue: Yes ]
Composite rate of major adverse events within 30 days or hospital discharge.
Composite rate of major adverse events within 30 days or hospital discharge. [ Time Frame: 30 days ]
Complete list of historical versions of study NCT00972270 on ClinicalTrials.gov Archive Site
Maximum CPO increase from baseline. [ Time Frame: Treatment ] [ Designated as safety issue: Yes ]
Maximum CPO increase from baseline.
Maximum CPO increase from baseline. [ Time Frame: 30 days ]
Not Provided
Not Provided
 
Trial Using Impella LP 2.5 System in Patients With Acute Myocardial Infarction Induced Hemodynamic Instability
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

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myocardial Infarction
  • 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.
  • Device: Intra-Aortic Balloon Pump
    The Intra-Aortic Balloon Pump consists of a cylindrical balloon that sits in the aorta and counterpulsates.
  • Experimental: IMPELLA LP 2.5
    Intervention: Device: Impella LP 2.5
  • Active Comparator: Intra-Aortic Balloon Pump
    Intervention: Device: Intra-Aortic Balloon Pump
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
September 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00972270
IDE: G080021
Yes
Karim Benali, MD/ Chief Medical Officer, Abiomed
Abiomed Inc.
Not Provided
Principal Investigator: William O'Neill, M.D. Not affiliated with Abiomed
Abiomed Inc.
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP