CentriMag Failure-to-Wean Post Approval Study

Last updated: December 6, 2024
Sponsor: Abbott Medical Devices
Overall Status: Completed

Phase

N/A

Condition

Heart Failure

Chest Pain

Congestive Heart Failure

Treatment

CentriMag Circulatory Support System

Clinical Study ID

NCT04464785
ABT-CIP-10336
  • Ages > 18
  • All Genders

Study Summary

The primary objective of this Post Approval Study is to report the proportion of patients surviving to 30 days post CentriMag support or to hospital discharge, whichever is longer. For subjects who do not recover and are bridged to a heart transplant or a long-term assist device, the primary endpoint is survival to induction of anesthesia for the surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject >18 years of age

  • Subject or legal representative has signed Informed Consent Form (ICF)

  • Subject has CentriMag Circulatory Support System implanted due to Failure To Weanfrom Cardiopulmonary Bypass

Exclusion

Exclusion Criteria:

• Concomitant use of Extracorporeal Membrane Oxygenation (ECMO) during CentriMag Circulatory Support System implantation due to FTW from CPB

Study Design

Total Participants: 32
Treatment Group(s): 1
Primary Treatment: CentriMag Circulatory Support System
Phase:
Study Start date:
December 30, 2020
Estimated Completion Date:
October 25, 2024

Connect with a study center

  • Baptist Healt Medical Center

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Stanford University Medical Center

    Palo Alto, California 94304
    United States

    Site Not Available

  • University of Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Advent Health Orlando

    Orlando, Florida 32803
    United States

    Site Not Available

  • Emory University Hospital

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Advocate Christ Medical Center

    Oak Lawn, Illinois 60453
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48104
    United States

    Site Not Available

  • University of Minnesota Medical Center Fairview

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Barnes Jewish Hospital

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • New York Presbyterian/ Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Carolinas Medical Center

    Charlotte, North Carolina 28206
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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