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

NCT00972270 | Terminated Phase 3 DMC

• 1 other identifier: IDE: G080021
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Acute Myocardial Infarction

Keywords

Arterial Occlusive Disease; Heart Diseases; Myocardial Ischemia; Vascular Disease; Arteriosclerosis; Ischemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Maximum CPO increase from baseline.

  Treatment

Study Arms (2)

IMPELLA LP 2.5

EXPERIMENTAL

Device: Impella LP 2.5

Intra-Aortic Balloon Pump

ACTIVE COMPARATOR

Device: Intra-Aortic Balloon Pump

Interventions

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.

IMPELLA LP 2.5

Intra-Aortic Balloon Pump DEVICE

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

Intra-Aortic Balloon Pump

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unwitnessed cardiac arrest
• Abnormalities of the aorta
• Recent stroke or TIA
• Mural thrombus in the left ventricle

Sponsors & Collaborators

• Abiomed Inc.: lead

Study Sites (11)

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Shawnee Mission

Shawnee Mission, Kansas, 66204, United States

Location

Valley Hospital

Hawthorne, New Jersey, 07506, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Riverside Methodist

Columbus, Ohio, 43214, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Pinnacle Health

Wormleysburg, Pennsylvania, 17043, United States

Location

York Hospital

York, Pennsylvania, 17403, United States

Location

Methodist Hospital

Houston, Texas, 77030, United States

Location

Intermountain Medical Center

Murray, Utah, 84157, United States

Location

MeSH Terms

Conditions

Arterial Occlusive Diseases; Heart Diseases; Myocardial Ischemia; Vascular Diseases; Arteriosclerosis; Ischemia

Interventions

Intra-Aortic Balloon Pumping

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Counterpulsation; Assisted Circulation; Surgical Procedures, Operative

Study Officials

• William O'Neill, M.D.

  Not affiliated with Abiomed

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 2, 2009
• First Posted: September 4, 2009
• Study Start: July 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: September 1, 2010
• Last Updated: March 21, 2011

Record last verified: 2011-03

Locations

US (11)