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CentriMag Failure-to-Wean Post Approval Study

Recruiting
18 years of age
Both
Phase N/A
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Overview

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

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 Wean from Cardiopulmonary Bypass

Exclusion Criteria: 

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

Study details

Heart Failure

NCT04464785

Abbott Medical Devices

25 January 2024

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