Acute Myocardial InfarctionPhase 3RECOVER IINCT00972270
Trial Using Impella LP 2.5 System in Patients With Acute Myocardial Infarction Induced Hemodynamic Instability
A Phase 3 study testing Impella LP 2.5 and Intra-Aortic Balloon Pump in people with Acute Myocardial Infarction, run by Abiomed Inc. at 11 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Impella LP 2.5 and Intra-Aortic Balloon Pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 11 sitesUnited States
- Study dates
- Jul 2008to Sep 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unwitnessed cardiac arrest
- Abnormalities of the aorta
- Recent stroke or TIA
- Mural thrombus in the left ventricle
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Chicago Medical Center
Chicago, Illinois, 60637
Ohio State University
Columbus, Ohio, 43210
Riverside Methodist
Columbus, Ohio, 43214
Hartford Hospital
Hartford, Connecticut, 06102
Valley Hospital
Hawthorne, New Jersey, 07506
Methodist Hospital
Houston, Texas, 77030
Intermountain Medical Center
Murray, Utah, 84157
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Shawnee Mission
Shawnee Mission, Kansas, 66204
Pinnacle Health
Wormleysburg, Pennsylvania, 17043
York Hospital
York, Pennsylvania, 17403
About this study
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
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.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Impella LP 2.5, Intra-Aortic Balloon Pump
- Keywords
- Arterial Occlusive Disease, Heart Diseases, Myocardial Ischemia, Vascular Disease, Arteriosclerosis, Ischemia
- Medical subject headings
- Arterial Occlusive Diseases, Heart Diseases, Myocardial Ischemia, Vascular Diseases, Arteriosclerosis, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impella LP 2.5Device
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.
Intra-Aortic Balloon PumpDevice
The Intra-Aortic Balloon Pump consists of a cylindrical balloon that sits in the aorta and counterpulsates.
| Study group | Role | What they receive |
|---|---|---|
| IMPELLA LP 2.5 | Experimental | Not described Receives: Device: Impella LP 2.5 |
| Intra-Aortic Balloon Pump | Active comparator | Not described Receives: Device: Intra-Aortic Balloon Pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite rate of major adverse events within 30 days or hospital discharge.
Composite rate of major adverse events within 30 days or hospital discharge.
Measured: 30 days or discharge
Secondary outcomes (1)
Maximum CPO increase from baseline.
Maximum CPO increase from baseline.
Measured: Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2009 (estimated)
- Study startJul 2008
- Primary completionAug 2010
- Study completionSep 2010
Why it stopped: Study closed due to insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Abiomed Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abiomed Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- William O'Neill, M.D., Principal investigator, Not affiliated with Abiomed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972270
- Sponsor's protocol ID
- IDE: G080021
- Acronym
- RECOVER II
- Status last verified
- Mar 2011
- First submitted
- 2 Sep 2009
- Last updated
- 21 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00972270
- Acronym / sponsor ID
- RECOVER II / IDE: G080021
- Conditions
- Acute Myocardial Infarction
- Keywords
- Arterial Occlusive Disease, Heart Diseases, Myocardial Ischemia, Vascular Disease, Arteriosclerosis, Ischemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed due to insufficient enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Abiomed Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 4 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMPELLA LP 2.5 | Experimental | Device: Impella LP 2.5 |
| Intra-Aortic Balloon Pump | Active comparator | Device: Intra-Aortic Balloon Pump |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- Unwitnessed cardiac arrest
- Abnormalities of the aorta
- Recent stroke or TIA
- Mural thrombus in the left ventricle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impella LP 2.5Insertion 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. | Device | IMPELLA LP 2.5 |
| Intra-Aortic Balloon PumpThe Intra-Aortic Balloon Pump consists of a cylindrical balloon that sits in the aorta and counterpulsates. | Device | Intra-Aortic Balloon Pump |
Primary outcome
Composite rate of major adverse events within 30 days or hospital discharge.
Time frame: 30 days or discharge
Composite rate of major adverse events within 30 days or hospital discharge.
1 secondary outcome
Maximum CPO increase from baseline.
Time frame: Treatment
Results and safety
The study was stopped early (reason given: Study closed due to insufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William O'Neill, M.D. principal investigator
Not affiliated with Abiomed
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Impella LP 2.5 and Intra-Aortic Balloon Pump in people with Acute Myocardial Infarction, run by Abiomed Inc. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study closed due to insufficient enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite rate of major adverse events within 30 days or hospital discharge. (time frame: 30 days or discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2011.