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

Abiomed logo

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)

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

Trial contacts and locations

11

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems