Trial Using Impella LP 2.5 System in Patients With Acute Myocardial Infarction Induced Hemodynamic Instability (RECOVER II)
This study has been terminated.
(Study closed due to insufficient enrollment)
Sponsor:
Abiomed Inc.
Information provided by:
Abiomed Inc.
ClinicalTrials.gov Identifier:
NCT00972270
First received: September 2, 2009
Last updated: March 18, 2011
Last verified: March 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myocardial Infarction |
Device: Impella LP 2.5 Device: Intra-Aortic Balloon Pump |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Abiomed Inc.:
Primary Outcome Measures:
- Composite rate of major adverse events within 30 days or hospital discharge. [ Time Frame: 30 days or discharge ] [ Designated as safety issue: Yes ]Composite rate of major adverse events within 30 days or hospital discharge.
Secondary Outcome Measures:
- Maximum CPO increase from baseline. [ Time Frame: Treatment ] [ Designated as safety issue: Yes ]Maximum CPO increase from baseline.
| Enrollment: | 1 |
| Study Start Date: | July 2008 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: IMPELLA LP 2.5 |
Device: Impella LP 2.5
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.
|
| Active Comparator: Intra-Aortic Balloon Pump |
Device: Intra-Aortic Balloon Pump
The Intra-Aortic Balloon Pump consists of a cylindrical balloon that sits in the aorta and counterpulsates.
|
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00972270
Locations
| United States, Connecticut | |
| Hartford Hospital | |
| Hartford, Connecticut, United States, 06102 | |
| United States, Illinois | |
| University of Chicago Medical Center | |
| Chicago, Illinois, United States, 60637 | |
| United States, Kansas | |
| Shawnee Mission | |
| Shawnee Mission, Kansas, United States, 66204 | |
| United States, New Jersey | |
| Valley Hospital | |
| Hawthorne, New Jersey, United States, 07506 | |
| United States, Ohio | |
| Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| Riverside Methodist | |
| Columbus, Ohio, United States, 43214 | |
| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Pinnacle Health | |
| Wormleysburg, Pennsylvania, United States, 17043 | |
| York Hospital | |
| York, Pennsylvania, United States, 17403 | |
| United States, Texas | |
| Methodist Hospital | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| Intermountain Medical Center | |
| Murray, Utah, United States, 84157 | |
Sponsors and Collaborators
Abiomed Inc.
Investigators
| Principal Investigator: | William O'Neill, M.D. | Not affiliated with Abiomed |
More Information
No publications provided
| Responsible Party: | Karim Benali, MD/ Chief Medical Officer, Abiomed |
| ClinicalTrials.gov Identifier: | NCT00972270 History of Changes |
| Other Study ID Numbers: | IDE: G080021 |
| Study First Received: | September 2, 2009 |
| Last Updated: | March 18, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Abiomed Inc.:
|
Arterial Occlusive Disease Heart Diseases Myocardial Ischemia |
Vascular Disease Arteriosclerosis Ischemia |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 21, 2013