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CentriMag Failure-to-Wean Post Approval Study

Recruiting
The primary objective of this PAS 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
All
18 Years and over
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
Device: CentriMag Circulatory Support System
Heart Failure
Clinics and Surgery Center (CSC)
Tracy Bui - tbui@umn.edu
Andrew Shaffer
Phase IV
STUDY00010696
NCT04464785
See this study on ClinicalTrials.gov