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

March 18, 2011 updated by: Abiomed Inc.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
    • Kansas
      • Shawnee Mission, Kansas, United States, 66204
        • Shawnee Mission
    • New Jersey
      • Hawthorne, New Jersey, United States, 07506
        • Valley Hospital
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
      • Wormleysburg, Pennsylvania, United States, 17043
        • Pinnacle Health
      • York, Pennsylvania, United States, 17403
        • York Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • Methodist Hospital
    • Utah
      • Murray, Utah, United States, 84157
        • Intermountain Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days or discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum CPO increase from baseline.
Time Frame: Treatment
Maximum CPO increase from baseline.
Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abiomed Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

September 2, 2009

First Submitted That Met QC Criteria

September 3, 2009

First Posted (Estimate)

September 4, 2009

Study Record Updates

Last Update Posted (Estimate)

March 21, 2011

Last Update Submitted That Met QC Criteria

March 18, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDE: G080021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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