CentriMag Failure-to-Wean Post Approval Study

  • STATUS
    Recruiting
  • days left to enroll
    6
  • participants needed
    32
  • sponsor
    Abbott Medical Devices
Updated on 16 August 2021
anesthesia

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.

Details
Condition Heart failure, Heart disease, Congestive Heart Failure, Cardiac Disease, cardiac failure, congestive heart disease
Treatment CentriMag Circulatory Support System
Clinical Study IdentifierNCT04464785
SponsorAbbott Medical Devices
Last Modified on16 August 2021

Eligibility

Yes No Not Sure

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

None
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Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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