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

Primary Purpose

Acute Myocardial Infarction

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Impella LP 2.5
Intra-Aortic Balloon Pump
Sponsored by
Abiomed Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Arterial Occlusive Disease, Heart Diseases, Myocardial Ischemia, Vascular Disease, Arteriosclerosis, Ischemia

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hartford Hospital
  • University of Chicago Medical Center
  • Shawnee Mission
  • Valley Hospital
  • Ohio State University
  • Riverside Methodist
  • University of Pittsburgh Medical Center
  • Pinnacle Health
  • York Hospital
  • Methodist Hospital
  • Intermountain Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IMPELLA LP 2.5

Intra-Aortic Balloon Pump

Arm Description

Outcomes

Primary Outcome Measures

Composite rate of major adverse events within 30 days or hospital discharge.
Composite rate of major adverse events within 30 days or hospital discharge.

Secondary Outcome Measures

Maximum CPO increase from baseline.
Maximum CPO increase from baseline.

Full Information

First Posted
September 2, 2009
Last Updated
March 18, 2011
Sponsor
Abiomed Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00972270
Brief Title
Trial Using Impella LP 2.5 System in Patients With Acute Myocardial Infarction Induced Hemodynamic Instability
Acronym
RECOVER II
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 Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Terminated
Why Stopped
Study closed due to insufficient enrollment
Study Start Date
July 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Abiomed Inc.

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Arterial Occlusive Disease, Heart Diseases, Myocardial Ischemia, Vascular Disease, Arteriosclerosis, Ischemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMPELLA LP 2.5
Arm Type
Experimental
Arm Title
Intra-Aortic Balloon Pump
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Impella LP 2.5
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Intra-Aortic Balloon Pump
Intervention Description
The Intra-Aortic Balloon Pump consists of a cylindrical balloon that sits in the aorta and counterpulsates.
Primary Outcome Measure Information:
Title
Composite rate of major adverse events within 30 days or hospital discharge.
Description
Composite rate of major adverse events within 30 days or hospital discharge.
Time Frame
30 days or discharge
Secondary Outcome Measure Information:
Title
Maximum CPO increase from baseline.
Description
Maximum CPO increase from baseline.
Time Frame
Treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William O'Neill, M.D.
Organizational Affiliation
Not affiliated with Abiomed
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Shawnee Mission
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Valley Hospital
City
Hawthorne
State/Province
New Jersey
ZIP/Postal Code
07506
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Riverside Methodist
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Pinnacle Health
City
Wormleysburg
State/Province
Pennsylvania
ZIP/Postal Code
17043
Country
United States
Facility Name
York Hospital
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States
Facility Name
Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84157
Country
United States

12. IPD Sharing Statement

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Trial Using Impella LP 2.5 System in Patients With Acute Myocardial Infarction Induced Hemodynamic Instability

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