CentriMag Failure-to-Wean Post Approval Study
- Conditions
- Heart Failure
- Registration Number
- NCT04464785
- Lead Sponsor
- Abbott Medical Devices
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- 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
• Concomitant use of Extracorporeal Membrane Oxygenation (ECMO) during CentriMag Circulatory Support System implantation due to FTW from CPB
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Survival to 30 days Post CentriMag support or to hospital discharge 30 days The proportion of subjects who survive to 30 days post CentriMag support or to hospital discharge (whichever is longer).
Survival to induction of anesthesia for surgery for transplant or a long-term system Approximately 30 days The proportion of subjects who do not recover and are bridged to a transplant or long-term system
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Baptist Healt Medical Center
🇺🇸Little Rock, Arkansas, United States
Advocate Christ Medical Center
🇺🇸Oak Lawn, Illinois, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
University of Minnesota Medical Center Fairview
🇺🇸Minneapolis, Minnesota, United States
Barnes Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Emory University Hospital🇺🇸Atlanta, Georgia, United States