Heart FailureNCT00819793
CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass
A study testing CentriMag Ventricular Assist System in people with Heart Failure, run by Abbott Medical Devices at 14 sites in United States.
Trial summary
The purpose of the study is to evaluate the safety and effectiveness of the CentriMag ventricular assist system to help patients who have experienced heart failure during surgery and cannot be removed from cardiac bypass. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- CentriMag Ventricular Assist System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 14 sitesUnited States
- Study dates
- Oct 2008to Sep 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Cardiac dysfunction due to failure-to-wean from cardiopulmonary bypass
- Subjects who are on IABP, CPB, ECMO or CPS support prior to evaluation should have the device turned off, if possible, for the purpose of measuring inclusion hemodynamics. However, these devices should not be turned off in patients who would be harmed by interruption of support.
- All subjects must meet the following criteria at the time of enrollment:
- Hemodynamics:
- cardiac index ≤ 2.2 L/min/m2
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- For patients being evaluated for left-sided support (LVAD): PCWP ≥ 18 mmHg or PADP ≥ 18 mmHg or LAP ≥ 18 mmHg
- For patients being evaluated for right or biventricular support: CVP ≥ 15 mmHg or RAP ≥ 15 mmHg and RVSWI ≤ 4.1 gm/m2/beat
- Enrollment without hemodynamic measurements due to frequent or unpredictable dysrhythmias, unacceptable cardiac function, or hemodynamic instability is allowed.
- Placement of an intra-aortic balloon pump has been attempted unless contraindicated
- All possible measures have been attempted to correct low arterial pH, arterial blood gas abnormalities, electrolytes, hypovolemia, hypervolemia, inadequate cardiac rate, dysrhythmias and residual hypothermia
- Cardiac resuscitation using pharmacologic agents, and epicardial pacing (if appropriate and possible) has been attempted
- Written, signed, and dated informed consent
Who cannot join
- BUN > 100 mg/dl
- Creatinine > 5 mg/dl
- Presence of any investigational mechanical circulatory support device
- Known history of liver cirrhosis or portal hypertension
- Pulmonary infarction
- Stroke, TIA or history of either condition within the last six months and/or any confirmed, existing neurologic deficits
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- Active systemic infection defined as positive blood cultures, core temperature >100.5 degrees, white blood count > 12,500, and treatment with antimicrobials
- Participation in a clinical trial with any experimental treatment within 30 days prior to screening or previous participation in the present study
- Other serious disease(s) limiting life expectancy
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
University of Maryland
Baltimore, Maryland, 21201
Duke University Medical Center
Durham, North Carolina, 27710
St. Luke's Episcopal
Houston, Texas, 77030
University of Kentucky
Lexington, Kentucky, 40536
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Fairview University Medical Center
Minneapolis, Minnesota, 55455
Intermountain Medical Center
Murray, Utah, 84107
Yale University
New Haven, Connecticut, 06510
New York Columbia Presbyterian Hospital
New York, New York, 10032
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic Hospital, Arizona
Phoenix, Arizona, 85054
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
University of Rochester
Rochester, New York, 14642
University of Utah
Salt Lake City, Utah, 84132
About this study
Official title: Thoratec CentriMag VAS Failure-to-Wean From Cardiopulmonary Bypass Trial
The purpose of the study is to evaluate the safety and effectiveness of the CentriMag ventricular assist system to help patients who have experienced heart failure during surgery and cannot be removed from cardiac bypass.
- Conditions
- Heart Failure
- Being tested
- CentriMag Ventricular Assist System
- Keywords
- Cardiac Dysfunction, Failure-to-wean from CPB, CentriMag, Levitronix, Thoratec Corporation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CentriMag Ventricular Assist SystemDevice
All eligible subjects will receive the CentriMag Ventricular Assist System. The system is comprised of a single-use centrifugal blood pump, a motor, a primary drive console, a back up drive console and cannulae. Blood from the failing heart is directed from the ventricle or the atrium to the inlet of the pump via an inlet cannula. Blood exits through the outlet port of the pump through the outlet cannula ultimately to the pulmonary or systemic circulation. The system can be used in either a right, left or biventricular configuration.
| Study group | Role | What they receive |
|---|---|---|
| CentriMag Ventricular Assist System | Experimental | All patients meeting the patient selection criteria will be treated with the CentriMag Ventricular Assist System. Receives: Device: CentriMag Ventricular Assist System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Number of patients alive 30 days after device implantation
Measured: 30 days post-support or to hospital discharge, whichever is longer OR to induction of anesthesia for implantation of a long-term device or heart transplant
Secondary outcomes (1)
Improvement in Central Venous Pressure (CVP) and Mean Arterial Blood Pressure (MAP)
Change in mean CVP while on pump support and in MAP during pump support. CVP and MAP were measured daily during pump support and the mean CVP and MAP during pump support were compared to baseline. Mean CVP or MAP during support (up to 30 days) minus baseline CVP or MAP.
Measured: Mean CVP or MAP during support (up to 30 days) minus baseline CVP or MAP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2009 (estimated)
- Study startOct 2008
- Primary completionMay 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Thoratec Corporation
- Responsible party
- Sponsor
- Investigators
- Pooja Chatterjee, Study director, Abbott Medical Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819793
- Sponsor's protocol ID
- LXP-002
- Status last verified
- Jun 2022
- First submitted
- 8 Jan 2009
- Last updated
- 27 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoratec CentriMag VAS Failure-to-Wean From Cardiopulmonary Bypass Trial
- ClinicalTrials.gov ID
- NCT00819793
- Acronym / sponsor ID
- LXP-002
- Conditions
- Heart Failure
- Keywords
- Cardiac Dysfunction, Failure-to-wean from CPB, CentriMag, Levitronix, Thoratec Corporation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- Thoratec Corporation
- Study start
- Oct 2008
- Primary completion
- May 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 9 Jan 2009 (estimated)
- Results
- Posted 19 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the safety and effectiveness of the CentriMag ventricular assist system to help patients who have experienced heart failure during surgery and cannot be removed from cardiac bypass.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CentriMag Ventricular Assist System | Experimental | Device: CentriMag Ventricular Assist SystemAll patients meeting the patient selection criteria will be treated with the CentriMag Ventricular Assist System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- At least 18 years of age
- Cardiac dysfunction due to failure-to-wean from cardiopulmonary bypass
- Subjects who are on IABP, CPB, ECMO or CPS support prior to evaluation should have the device turned off, if possible, for the purpose of measuring inclusion hemodynamics. However, these devices should not be turned off in patients who would be harmed by interruption of support.
- All subjects must meet the following criteria at the time of enrollment:
- Hemodynamics:
Key exclusion criteria (9 listed)
- BUN > 100 mg/dl
- Creatinine > 5 mg/dl
- Presence of any investigational mechanical circulatory support device
- Known history of liver cirrhosis or portal hypertension
- Pulmonary infarction
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 |
|---|---|---|
| CentriMag Ventricular Assist SystemAll eligible subjects will receive the CentriMag Ventricular Assist System. The system is comprised of a single-use centrifugal blood pump, a motor, a primary drive console, a back up drive console and cannulae. Blood from the failing heart is directed from the ventricle or the atrium to the inlet of the pump via an inlet cannula. Blood exits through the outlet port of the pump through the outlet cannula ultimately to the pulmonary or systemic circulation. The system can be used in either a right, left or biventricular configuration. | Device | CentriMag Ventricular Assist System |
Primary outcome
Survival
Time frame: 30 days post-support or to hospital discharge, whichever is longer OR to induction of anesthesia for implantation of a long-term device or heart transplant
Number of patients alive 30 days after device implantation
1 secondary outcome
Improvement in Central Venous Pressure (CVP) and Mean Arterial Blood Pressure (MAP)
Time frame: Mean CVP or MAP during support (up to 30 days) minus baseline CVP or MAP
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Pooja Chatterjee study director
Abbott Medical Devices
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CentriMag Ventricular Assist System in people with Heart Failure, run by Abbott Medical Devices at 14 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 13 inclusion and 9 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: finished, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Survival (time frame: 30 days post-support or to hospital discharge, whichever is longer OR to induction of anesthesia for implantation of a long-term device or heart transplant). 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 27 Jun 2022.