Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: RECOVER I: IMPELLA® RECOVER® LP/LD 5.0 Support System: A Clinical Safety & Feasibility Study

Resource links provided by NLM:


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 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 ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

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

Locations
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Brigham & Womens
Boston, Massachusetts, United States, 02115
Massach General Hospital
Boston, Massachusetts, United States, 02114
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

No publications provided

Responsible Party: Bartley Griffith M.D., University of Maryland, MD
ClinicalTrials.gov Identifier: NCT00596726     History of Changes
Other Study ID Numbers: G030202
Study First Received: January 8, 2008
Last Updated: May 25, 2010
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-operatively meet the study inclusion criteria are potential study candidates.

ClinicalTrials.gov processed this record on November 20, 2014