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Impella Recover LP/LD 5.0 Support System: A Clinical Safety & Feasibility Study

This trial is no longer in process.

Summary of Trial:	The purpose of this study is to demonstrate the safety and potential effectiveness of this device as left ventricular assist device for post-cardiotomy patients who require hemodynamic support after weaning from cardiopulmonary bypass machine. It is intended for use for up to seven days.
Principal Investigators:	Drs. Ashish Shah and John Conte
Study Coordinators:	Dzifa Dordunoo, MSN, RN Email: edordun1@jhmi.edu (410) 955-3597 Tamara Bubb, BS Email: tbubb1@jhmi.edu (410) 502-5438
Study Long Title:	Impella Recover LP/LD 5.0 Support System: A Clinical Safety & Feasibility Study
Study Short Title:	N/A
JHU eIRB Number:	NA_00021191
Funding Source:	ABIOMED, Inc.
Inclusions:	Receiving stable infusion of on high dose inotrope or two medium dose inotropes for a respective minimum time indicated Elevated filling pressures, pulmonary capillary wedge pressure (PCWP) or pulmonary artery pressure (PA) Time to enrollment within 48 hours from weaning
Exclusions:	Renal dysfunction Hepatic dysfunction Right Ventricular failure defined LV or RV Thrombus Other exclusions per protocol
Clinical Trial Site:	Johns Hopkins Hospital 600 North Wolfe Street, Blalock 618 Baltimore, MD 21287-4618 This is a multi-center study – there are 8 sites across the U.S. that are participating in this clinical trial.
Start Date:	May 2009
Anticipated End Date:	N/A
Compensation for Participating:	None

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