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.
Study Type
OBSERVATIONAL
Enrollment
32
The CentriMag Circulatory Suppose System is indicated for providing support for up to 30 days for one or both ventricles of the heart to treat post-cardiotomy patients who fail-to-wean from cardiopulmonary bypass, providing a bridge to decision when it is unclear whether the patient's heart will recover or whether the patient will need alternative, longer-term therapy.
Baptist Healt Medical Center
Little Rock, Arkansas, United States
Emory University Hospital
Atlanta, Georgia, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
University of Michigan
Ann Arbor, Michigan, United States
Survival to 30 days Post CentriMag support or to hospital discharge
The proportion of subjects who survive to 30 days post CentriMag support or to hospital discharge (whichever is longer).
Time frame: 30 days
Survival to induction of anesthesia for surgery for transplant or a long-term system
The proportion of subjects who do not recover and are bridged to a transplant or long-term system
Time frame: Approximately 30 days
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University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, United States
Barnes Jewish Hospital
St Louis, Missouri, United States
University of Utah
Salt Lake City, Utah, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States