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

This study has been completed.
Sponsor:
Information provided by:
Abiomed Inc.
ClinicalTrials.gov Identifier:
NCT00596726
First received: January 8, 2008
Last updated: May 25, 2010
Last verified: May 2010

January 8, 2008
May 25, 2010
August 2006
April 2010   (final data collection date for primary outcome measure)
Frequency of Major Adverse Events [ Time Frame: 30 day or discharge ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00596726 on ClinicalTrials.gov Archive Site
Other Adverse Events Doppler echocardiography 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 ]
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 ]
Not Provided
Not Provided
 
RECOVER I Impella RECOVER LP/LD 5.0 Support System Safety and Feasibility Study
RECOVER I: IMPELLA® RECOVER® LP/LD 5.0 Support System: A Clinical Safety & Feasibility Study

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.

To demonstrate 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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cardiac Surgery
Device: IMPELLA LP/LD 5.0
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
May 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Renal dysfunction
  • Hepatic dysfunction
  • Right Ventricular failure defined.
  • LV or RV Thrombus
  • Other exclusions per protocol
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00596726
G030202
No
Bartley Griffith M.D., University of Maryland, MD
Abiomed Inc.
Not Provided
Principal Investigator: Bartley Griffith, M.D. University of Maryland
Principal Investigator: Mark Anderson Robert Wood Johnson Foundation
Abiomed Inc.
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP