RECOVER II Trial: A Prospective Randomized Trial Investigating the Use of the IMPELLA RECOVER LP 2.5 System in Patients With Acute Myocardial Infarction Induced Hemodynamic Instability
| Registry | NCT00972270, acronym RECOVER II |
|---|---|
| Status | Terminated - Study closed due to insufficient enrollment |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 1 (Actual) |
| Sponsor | Abiomed Inc. (Industry) |
| Conditions | Acute Myocardial Infarction |
| Interventions | Impella LP 2.5, Intra-Aortic Balloon Pump (Device) |
| Dates | start 2008-07-01, primary completion 2010-08-01, completion 2010-09-01, first posted 2009-09-04, last updated 2011-03-21 |
| Locations | 11 sites in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Acute Myocardial Infarction All trials of Impella LP 2.5 All trials of Intra-Aortic Balloon Pump
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| IMPELLA LP 2.5 | Experimental | Device: Impella LP 2.5 | |
| Intra-Aortic Balloon Pump | Active comparator | Device: Intra-Aortic Balloon Pump |
Sex: All, ages: 18 Years to 90 Years
Inclusion Criteria: * Informed Consent * Subject presenting with STEMI undergoing primary PCI * Patient presents with at least 1 of the following: * Unstable blood pressure * Tachycardia and tissue hypoperfusion * The need for intravenous pressor or inotropic support * Patient presents with STEMI: * CK-MB>2x normal Exclusion Criteria: * Unwitnessed cardiac arrest * Abnormalities of the aorta * Recent stroke or TIA * Mural thrombus in the left ventricle
| Facility | City | Country | Status |
|---|---|---|---|
| Hartford Hospital | Hartford, Connecticut | United States | |
| University of Chicago Medical Center | Chicago, Illinois | United States | |
| Shawnee Mission | Shawnee Mission, Kansas | United States | |
| Valley Hospital | Hawthorne, New Jersey | United States | |
| Ohio State University | Columbus, Ohio | United States | |
| Riverside Methodist | Columbus, Ohio | United States | |
| University of Pittsburgh Medical Center | Pittsburgh, Pennsylvania | United States | |
| Pinnacle Health | Wormleysburg, Pennsylvania | United States | |
| York Hospital | York, Pennsylvania | United States | |
| Methodist Hospital | Houston, Texas | United States | |
| Intermountain Medical Center | Murray, Utah | United States |