RECOVER I Impella RECOVER LP/LD 5.0 Support System Safety and Feasibility Study

Completed · Phase 2

Conditions studied: Cardiac Surgery

In brief

To demonstrate that that the device is safe and potentially efficacious for use as a left ventricular cardiac assist device for postcardiotomy patients who require hemodynamic support post weaning from cardiopulmonary bypass.

Key facts

Study ID

NCT00596726

Run by

Abiomed Inc.

People needed

17

Starts

2006-08-01

Expected to finish

2010-05-01

Last updated by the study team

2010-05-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• BSA
• Receiving stable infusion of one high dose inotrope or two medium dose inotropes for a respective minimum time indicated.
• C.I.
• Elevated Filling Pressures, PCWP or PA
• Time to enrollment within 48 hours from weaning

You may not qualify if…

• Renal dysfunction
• Hepatic dysfunction
• Right Ventricular failure defined.
• LV or RV Thrombus
• Other exclusions per protocol

Where it is running

• University of Maryland — Baltimore, Maryland, United States
• Massach General Hospital — Boston, Massachusetts, United States
• Brigham & Womens — Boston, Massachusetts, United States
• Robert Wood Johnson — New Brunswick, New Jersey, United States
• Columbia Presbyterian Hospital — New York, New York, United States
• Hershey Medical Center — Hershey, Pennsylvania, United States
• Texas Heart — Houston, Texas, United States

Full record on ClinicalTrials.gov

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