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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Subjects who receive the CentriMag Circulatory Support System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CentriMag Circulatory Support System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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 | Approximately 30 days |
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Inclusion Criteria:
Exclusion Criteria:
• Concomitant use of Extracorporeal Membrane Oxygenation (ECMO) during CentriMag Circulatory Support System implantation due to FTW from CPB
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Male and female subjects who fail-to-wean from cardiopulmonary bypass.
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| Name | Affiliation | Role |
|---|---|---|
| Brian Crowe | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Healt Medical Center | Little Rock | Arkansas | 72205 | United States | ||
| Emory University Hospital |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | United States |
| University of Michigan | Ann Arbor | Michigan | 48104 | United States |
| University of Minnesota Medical Center Fairview | Minneapolis | Minnesota | 55455 | United States |
| Barnes Jewish Hospital | St Louis | Missouri | 63110 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |