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| Name | Class |
|---|---|
| Thoratec Corporation | INDUSTRY |
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The purpose of the study is to evaluate the safety and effectiveness of the CentriMag ventricular assist system to help pediatric patients who have experienced heart failure during surgery and cannot be removed from cardiac bypass.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Patients | Other | All patients meeting the patient selection criteria will be treated with the CentriMag device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CentriMag Ventricular Assist System | Device | All patients will be treated with the CentriMag device for up to 30 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Survival | In patients who recover and do not go on to transplantation or a long-term device: • Survival 30 days after removal of the CentriMag VAS or to discharge, whichever is longer. In patients who do not recover: • Ability to be removed from the CentriMag VAS and survive to induction of anesthesia for implantation of a long-term device or heart transplantation. | 30 days after device removal, or, induction of anesthesia for implant of a long-term device or heart transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of end-organ function | Improvements in measures of end-organ function | 30 days after device removal, or, to induction of anesthesia for implant of a long-term device or heart transplant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pooja Chatterjee | Thoratec Corporation/Abbott | Study Director |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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