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
  Purpose

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 Intervention Phase
Acute Myocardial Infarction
Device: Impella LP 2.5
Device: Intra-Aortic Balloon Pump
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Abiomed Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Maximum CPO increase from baseline. [ Time Frame: Treatment ] [ Designated as safety issue: Yes ]
    Maximum CPO increase from baseline.


Enrollment: 1
Study Start Date: July 2008
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00972270

Locations
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.
Investigators
Principal Investigator: William O'Neill, M.D. Not affiliated with Abiomed
  More Information

No publications provided

Responsible Party: Karim Benali, MD/ Chief Medical Officer, Abiomed
ClinicalTrials.gov Identifier: NCT00972270     History of Changes
Other Study ID Numbers: IDE: G080021
Study First Received: September 2, 2009
Last Updated: March 18, 2011
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 28, 2014