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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00596726
First Posted: January 17, 2008
Last Update Posted: May 27, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abiomed Inc.
  Purpose
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.

Condition Intervention Phase
Cardiac Surgery Device: IMPELLA LP/LD 5.0 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RECOVER I: IMPELLA® RECOVER® LP/LD 5.0 Support System: A Clinical Safety & Feasibility Study

Further study details as provided by Abiomed Inc.:

Primary Outcome Measures:
  • Frequency of Major Adverse Events [ Time Frame: 30 day or discharge ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 17
Study Start Date: August 2006
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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
Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00596726


Locations
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Massach General Hospital
Boston, Massachusetts, United States, 02114
Brigham & Womens
Boston, Massachusetts, United States, 02115
United States, New Jersey
Robert Wood Johnson
New Brunswick, New Jersey, United States, 08903
United States, New York
Columbia Presbyterian Hospital
New York,, New York, United States, 10032
United States, Pennsylvania
Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, Texas
Texas Heart
Houston, Texas, United States, 777030
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

Responsible Party: Bartley Griffith M.D., University of Maryland, MD
ClinicalTrials.gov Identifier: NCT00596726     History of Changes
Other Study ID Numbers: G030202
First Submitted: January 8, 2008
First Posted: January 17, 2008
Last Update Posted: May 27, 2010
Last Verified: May 2010

Keywords provided by Abiomed Inc.:
All patients presenting for high-risk cardiac surgery and who might post-operatively meet the study inclusion criteria are potential study candidates.


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