Status:
COMPLETED
CentriMag Failure-to-Wean Post Approval Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief 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...
Eligibility Criteria
Inclusion
- 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
- • Concomitant use of Extracorporeal Membrane Oxygenation (ECMO) during CentriMag Circulatory Support System implantation due to FTW from CPB
Key Trial Info
Start Date :
December 30 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 25 2024
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04464785
Start Date
December 30 2020
End Date
October 25 2024
Last Update
December 11 2024
Active Locations (8)
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1
Baptist Healt Medical Center
Little Rock, Arkansas, United States, 72205
2
Emory University Hospital
Atlanta, Georgia, United States, 30322
3
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453
4
University of Michigan
Ann Arbor, Michigan, United States, 48104