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Study closed due to insufficient enrollment
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This is a randomized trial investigating the use of the IMPELLA RECOVER LP 2.5 compared to Intra-aortic balloon pump (IABP) in patients with Acute Myocardial Infarction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMPELLA LP 2.5 | Experimental |
| |
| Intra-Aortic Balloon Pump | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Impella LP 2.5 | Device | Insertion of the LP 2.5 IMPELLA circulatory support system that can be placed across the aortic valve using a single femoral site. The device pumps blood from the left ventricle into the ascending aorta at 2.5L/min. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite rate of major adverse events within 30 days or hospital discharge. | Composite rate of major adverse events within 30 days or hospital discharge. | 30 days or discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum CPO increase from baseline. | Maximum CPO increase from baseline. | Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William O'Neill, M.D. | Not affiliated with Abiomed | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford Hospital | Hartford | Connecticut | 06102 | United States | ||
| University of Chicago Medical Center |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 3, 2013 | |
| Reset | Jun 20, 2013 |
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| Intra-Aortic Balloon Pump | Device | The Intra-Aortic Balloon Pump consists of a cylindrical balloon that sits in the aorta and counterpulsates. |
|
| Chicago |
| Illinois |
| 60637 |
| United States |
| Shawnee Mission | Shawnee Mission | Kansas | 66204 | United States |
| Valley Hospital | Hawthorne | New Jersey | 07506 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Riverside Methodist | Columbus | Ohio | 43214 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Pinnacle Health | Wormleysburg | Pennsylvania | 17043 | United States |
| York Hospital | York | Pennsylvania | 17403 | United States |
| Methodist Hospital | Houston | Texas | 77030 | United States |
| Intermountain Medical Center | Murray | Utah | 84157 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 3, 2013 | Jun 20, 2013 |
| ID | Term |
|---|---|
| D001157 | Arterial Occlusive Diseases |
| D006331 | Heart Diseases |
| D017202 | Myocardial Ischemia |
| D014652 | Vascular Diseases |
| D001161 | Arteriosclerosis |
| D007511 | Ischemia |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007423 | Intra-Aortic Balloon Pumping |
| ID | Term |
|---|---|
| D015908 | Counterpulsation |
| D001243 | Assisted Circulation |
| D013514 | Surgical Procedures, Operative |
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