Heart Failure
Conditions
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.
Interventions
DEVICECentriMag Circulatory Support System
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.
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed