CentriMag Failure-to-Wean Post-Approval Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Medical Devices
- Enrollment
- 32
- Locations
- 8
- Primary Endpoint
- Survival to 30 days Post CentriMag support or to hospital discharge
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Concomitant use of Extracorporeal Membrane Oxygenation (ECMO) during CentriMag Circulatory Support System implantation due to FTW from CPB
Outcomes
Primary Outcomes
Survival to 30 days Post CentriMag support or to hospital discharge
Time Frame: 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
Time Frame: Approximately 30 days
The proportion of subjects who do not recover and are bridged to a transplant or long-term system
Secondary Outcomes
No secondary outcomes reported