RECOVER I Impella RECOVER LP/LD 5.0 Support System: A Clinical Safety & Feasibility Study - Full Text View

Sponsored by:	Abiomed Inc.
Information provided by:	Abiomed Inc.
ClinicalTrials.gov Identifier:	NCT00596726

Purpose

To demostarate 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.

Condition	Intervention	Phase
Cardiac Surgery	Device: IMPELLA LP/LD 5.0	Phase I

Study Type:	Interventional
Study Design:	Supportive Care, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	RECOVER I Impella RECOVER LP/LD 5.0 Support System: A Clinical Safety &

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery Surgery

U.S. FDA Resources

Further study details as provided by Abiomed Inc.:

Primary Outcome Measures:

Frequency of Major Adverse Events [ Time Frame: 30 day or discharge ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Other Adverse Events Doppler echocardography assessment of aortic valve function will be performed at explant and 30days and 3 month follow-ups. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	August 2006
Estimated Study Completion Date:	April 2008
Estimated Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Intervention Details:

IMPELLA LP/LD 5.0 Support System is intended to be used for up to seven (7) days as a left ventricular cardiac assist device for postcardiotomy patients who, despite having been weaned from cardiopulmonary bypass (CPB), require hemodynamic support

Detailed Description:

To demostarate 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.

Postcardiotomy patients, weaned from a cardiopulmonary bypass system (CPB) in need for hemodynamic support due to ineffective standard medical therapy will be considered for enrollment. An attempt shall be made to reverse the hemodynamic situation with medications (e.g. inotropes, vasopressors). The IMPELLA RECOVER LP/LD 5.0 will be implanted by the surgeon when no improvement in hemodynamics is observed.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

BSA
Recieving stable infusion of on 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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596726

Contacts

Contact: Ioana Ghiu	978-239-8734	ighiu@abiomed.com
Contact: Karim Benali	978-646-1800	kbenali@abiomed.com

Locations

United States, Maryland
University of Maryland	Recruiting
Baltimore, Maryland, United States, 21201
Principal Investigator: Bartley Griffith
United States, New Jersey
Robert Wood Johnson	Recruiting
New Brunswick, New Jersey, United States, 08903
Principal Investigator: Mark Anderson

Sponsors and Collaborators

Abiomed Inc.

Investigators

Principal Investigator:	Bartley Griffith, M.D.	University of Maryland
Principal Investigator:	Mark Anderson	Robert Wood Johnson Foundation

More Information

No publications provided

Responsible Party:	University of Maryland, MD ( Bartley Griffith M.D. )
Study ID Numbers:	G030202
Study First Received:	January 8, 2008
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00596726 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abiomed Inc.:

All patients presenting for high-risk cardiac surgery and who might post-opertively meet the study inclusion criteria are potential study candidates.

ClinicalTrials.gov processed this record on September 11, 2009