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| Name | Class |
|---|---|
| Abiomed Inc. | INDUSTRY |
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The present study introduces a novel approach to coronary revascularization through the use of a short term minimally-invasive left ventricular assist device (LVAD) to minimize myocardial injury and eliminate low output state during the perioperative period
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Impella 5.5 with SmartAssist Supported OPCABG | Device | Subjects will undergo insertion of an axillary or ascending aortic Impella 5.5 with SmartAssist, followed by Impella-supported OPCABG using a sternotomy approach with shunting of the coronary arteries to achieve myocardial protection. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative hemodynamic stability | Intraoperative hemodynamic stability, defined as mean arterial pressure (MAP), cardiac index (CI), central venous pressure (CVP), and cerebral perfusion as measured by NIRS maintained within normal ranges for the entire operative time except potentially for short periods not exceeding 10 minutes in total time. | Intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria will include the existing contraindications to either Impella therapy or OPCABG revascularization:
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Patients fitting inclusion criteria will undergo Impella supported OPCABG using coronary shunts. Inclusion criteria will target patients with ischemic cardiomyopathy, similarly defined to the STICH trial which evaluated coronary revascularization in the setting of heart failure (defined by an EF≤35%). Patients would be considered for enrollment in the setting of symptomatic severe multi-vessel coronary artery disease with target vessels that are amenable to bypass (as determined by the operating surgeon).
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| Name | Affiliation | Role |
|---|---|---|
| Lucian A Durham, MD, PhD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
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