|Principal Investigator: Craig Selzman|
|Keywords: Cardiothoracic Surgery , Mechanical Circulatory Support , Heart Failure||Department: Cardiothoracic Division|
|IRB Number: 00138405|
|Specialty: Cardiothoracic Surgery|
|Sub Specialties: Heart Failure|
|Recruitment Status: Recruiting|
This study will fulfil a PAS requirement as part of the FDA condition of approval for providing support for up to 30 days for one or both sides of the heart to treat post-cardiotomy patients who fail-to-wean (FTW) from cardiopulmonary bypass (CPB) post-market approval (PMA) approval (P170038). The purpose of this study is to gather real-world information on the post-market performance, and confirm safety and effectiveness of the CentriMag Circulatory Support System for patients surviving up 30 days post support or to hospital discharge, whichever is longer; and for subjects who do not recover and are bridged to a heart transplant or long-term assist device, the endpoint is survival to induction of anesthesia for the surgery.
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.
• Subject >=18 years of age
• Subject or legal representative has signed Informed Consent Form (ICF)
• Subject has CentriMag Circulatory Support System implanted due to FTW from CPB