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

NCT00972270 — Phase 3, Terminated, 1 participants, Abiomed Inc.

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

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

RegistryNCT00972270, acronym RECOVER II
StatusTerminated - Study closed due to insufficient enrollment
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment1 (Actual)
SponsorAbiomed Inc. (Industry)
ConditionsAcute Myocardial Infarction
InterventionsImpella LP 2.5, Intra-Aortic Balloon Pump (Device)
Datesstart 2008-07-01, primary completion 2010-08-01, completion 2010-09-01, first posted 2009-09-04, last updated 2011-03-21
Locations11 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Acute Myocardial Infarction All trials of Impella LP 2.5 All trials of Intra-Aortic Balloon Pump

-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.

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
IMPELLA LP 2.5ExperimentalDevice: Impella LP 2.5
Intra-Aortic Balloon PumpActive comparatorDevice: Intra-Aortic Balloon Pump
  • Impella LP 2.5 (Device): 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.
  • Intra-Aortic Balloon Pump (Device): The Intra-Aortic Balloon Pump consists of a cylindrical balloon that sits in the aorta and counterpulsates.

+Outcome measures

Primary outcomes

  • Composite rate of major adverse events within 30 days or hospital discharge. [30 days or discharge]: Composite rate of major adverse events within 30 days or hospital discharge.

Secondary outcomes

  • Maximum CPO increase from baseline. [Treatment]: Maximum CPO increase from baseline.

+Eligibility

Sex: All, ages: 18 Years to 90 Years

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

+Locations (11)

FacilityCityCountryStatus
Hartford HospitalHartford, ConnecticutUnited States
University of Chicago Medical CenterChicago, IllinoisUnited States
Shawnee MissionShawnee Mission, KansasUnited States
Valley HospitalHawthorne, New JerseyUnited States
Ohio State UniversityColumbus, OhioUnited States
Riverside MethodistColumbus, OhioUnited States
University of Pittsburgh Medical CenterPittsburgh, PennsylvaniaUnited States
Pinnacle HealthWormleysburg, PennsylvaniaUnited States
York HospitalYork, PennsylvaniaUnited States
Methodist HospitalHouston, TexasUnited States
Intermountain Medical CenterMurray, UtahUnited States

+Investigators