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The population enrolled in this study are all subjects who received an Impella in which a bicarbonate-based purge solution was used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Left sided device | All patients implanted with a left sided support Impella device - this includes but is not limited to Impella 2.5, Impella CP, Impella 5.0, Impella 5.5. |
| |
| Right sided device | All patients implanted with a right sided support Impella device -this includes the Impella RP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Impella CP, 2.5, 5.0 and 5.5 with Sodium Bicarbonate used as purge solution | Device | US commercially approved Abiomed left sided hemodynamic support devices (Impella) will be included. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint Left Sided Impella | Rate of heiarchical composite of stroke, transient ischemic attack (TIA), left ventricular (LV) thrombus | From hospital admission until hospital discharge, average 5 days |
| Primary Endpoint Right Sided Impella | Rate of heiarchical composite of pulmonary thromboemboli and deep vein thrombosis (DVT) | From hospital admission until hospital discharge, average 5 days |
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Left Sided Impella
Inclusion Criteria:
Exclusion Criteria:
Right Sided Impella
Inclusion Criteria:
Exclusion Criteria:
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All subjects who received an Impella in which a bicarbonate-based purge solution was used
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| Name | Affiliation | Role |
|---|---|---|
| Amin Medjamia, MD | Abiomed Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35233 | United States | ||
| Pima Heart and Vascular (Tuscon Medical Center) |
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| Impella RP with Sodium Bicarbonate used as purge solution | Device | US commercially approved Abiomed right sided hemodynamic support devices (Impella) will be included. |
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| Tucson |
| Arizona |
| 85712 |
| United States |
| Arkansas Heart Hospital | Little Rock | Arkansas | 72211 | United States |
| Keck USC Medical Center | Los Angeles | California | 90033 | United States |
| Advent Helath Orlando | Orlando | Florida | 32804 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Henry Ford | Detroit | Michigan | 48202 | United States |
| Ascension St. John Hospital | Detroit | Michigan | 48236 | United States |
| Providence St. Patrick | Missoula | Montana | 59802 | United States |
| University of Nebraska | Omaha | Nebraska | 68105 | United States |
| Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08901 | United States |
| Christ Hospital | Cincinnatti | Ohio | 45219 | United States |
| Montefiore Medical Center - Moses | Portland | Oregon | 97205 | United States |
| Legacy Emanuel | Portland | Oregon | 97227 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| UPMC Presbyterian | Pittsburgh | Pennsylvania | 15213 | United States |
| Baylor Scott and White (Baylor Heart and Vascular) | Dallas | Texas | 75226 | United States |
| The Heart Hospital Baylor Plano | Plano | Texas | 75093 | United States |
| Providence Sacred Heart | Spokane | Washington | 99204 | United States |
| MultiCare Tacoma General | Tacoma | Washington | 98405 | United States |
| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |
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