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

Acute Myocardial Infarction Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00972270
• Other study ID #: IDE: G080021
• Status: Terminated
• Phase: Phase 3
• First received: September 2, 2009
• Last updated: March 18, 2011
• Start date: July 2008
• Est. completion date: September 2010

Study information

• Verified date: March 2011
• Source: Abiomed Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Device:
• Impella LP 2.5
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
The Intra-Aortic Balloon Pump consists of a cylindrical balloon that sits in the aorta and counterpulsates.

Locations

Country	Name	City	State
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Ohio State University	Columbus	Ohio
United States	Riverside Methodist	Columbus	Ohio
United States	Hartford Hospital	Hartford	Connecticut
United States	Valley Hospital	Hawthorne	New Jersey
United States	Methodist Hospital	Houston	Texas
United States	Intermountain Medical Center	Murray	Utah
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Shawnee Mission	Shawnee Mission	Kansas
United States	Pinnacle Health	Wormleysburg	Pennsylvania
United States	York Hospital	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abiomed Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite rate of major adverse events within 30 days or hospital discharge.	Composite rate of major adverse events within 30 days or hospital discharge.	30 days or discharge
Secondary	Maximum CPO increase from baseline.	Maximum CPO increase from baseline.	Treatment