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

Abiomed

Status and phase: Terminated; Phase 3

Conditions: Acute Myocardial Infarction

Treatments: Device: Intra-Aortic Balloon Pump; Device: Impella LP 2.5

Study type: Interventional

Funder types: Industry

Identifiers

NCT00972270

IDE: G080021

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

IMPELLA LP 2.5

Experimental group

Treatment:

Device: Impella LP 2.5

Intra-Aortic Balloon Pump

Active Comparator group

Treatment:

Device: Intra-Aortic Balloon Pump