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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
Sponsor:
Information provided by:
Abiomed Inc.

Tracking Information
First Submitted Date  ICMJE September 2, 2009
First Posted Date  ICMJE September 4, 2009
Last Update Posted Date March 21, 2011
Study Start Date  ICMJE July 2008
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2010)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 3, 2009)
Composite rate of major adverse events within 30 days or hospital discharge. [ Time Frame: 30 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2010)
Maximum CPO increase from baseline. [ Time Frame: Treatment ]
Maximum CPO increase from baseline.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2009)
Maximum CPO increase from baseline. [ Time Frame: 30 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial Using Impella LP 2.5 System in Patients With Acute Myocardial Infarction Induced Hemodynamic Instability
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Myocardial Infarction
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: IMPELLA LP 2.5
    Intervention: Device: Impella LP 2.5
  • Active Comparator: Intra-Aortic Balloon Pump
    Intervention: Device: Intra-Aortic Balloon Pump
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 25, 2010)
1
Original Enrollment  ICMJE
 (submitted: September 3, 2009)
384
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00972270
Other Study ID Numbers  ICMJE IDE: G080021
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Karim Benali, MD/ Chief Medical Officer, Abiomed
Study Sponsor  ICMJE Abiomed Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: William O'Neill, M.D. Not affiliated with Abiomed
PRS Account Abiomed Inc.
Verification Date March 2011

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