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

Phase 3TerminatedNCT00972270

Abiomed Inc.1 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Myocardial Infarction

Interventions

Impella LP 2.5DEVICE

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 PumpDEVICE

The Intra-Aortic Balloon Pump consists of a cylindrical balloon that sits in the aorta and counterpulsates.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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)

Hartford Hospital

Hartford, Connecticut, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Shawnee Mission

Shawnee Mission, Kansas, United States

Outcomes

Primary Outcomes

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

Time frame: 30 days or discharge

Secondary Outcomes

Maximum CPO increase from baseline.

Time frame: Treatment

Data from ClinicalTrials.gov

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