Heart FailureNCT01171950
CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass for Pediatric Patients
A study testing CentriMag Ventricular Assist System in people with Heart Failure, run by Abbott Medical Devices.
Trial summary
The purpose of the study is to evaluate the safety and effectiveness of the CentriMag ventricular assist system to help pediatric 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 5 to 16 years
- 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Dec 2012
- Phase
- Interventional
- 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 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 5 years to 16 years, inclusive
- Inability to wean from cardiopulmonary bypass (CPB)
Who cannot join
- Body weight < 20 kg
- Severe aortic insufficiency
- Unrestricted intra-cardiac communications (i.e. large VSD)
- Pulmonary vascular resistance index (PVRI) > 10 IU
- Presence of DIC
- On hemodialysis (excluding hemofiltration)
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- Contraindications to systemic anticoagulation
- Active systemic infection unresponsive to antibiotics
- Unresolved malignancy
- On other investigational VAS
About this study
Official title: CentriMag Ventricular Assist System (VAS): Treatment of Failure-to-Wean From Cardiopulmonary Bypass for Pediatric Patients
The purpose of the study is to evaluate the safety and effectiveness of the CentriMag ventricular assist system to help pediatric 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
- 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 patients will be treated with the CentriMag device for up to 30 days.
| Study group | Role | What they receive |
|---|---|---|
| All Patients | Other | All patients meeting the patient selection criteria will be treated with the CentriMag device. Receives: Device: CentriMag Ventricular Assist System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
In patients who recover and do not go on to transplantation or a long-term device:
- Survival 30 days after removal of the CentriMag VAS or to discharge, whichever is longer.
In patients who do not recover:
- Ability to be removed from the CentriMag VAS and survive to induction of anesthesia for implantation of a long-term device or heart transplantation.
Measured: 30 days after device removal, or, induction of anesthesia for implant of a long-term device or heart transplant
Secondary outcomes (1)
Evaluation of end-organ function
Improvements in measures of end-organ function
Measured: 30 days after device removal, or, to induction of anesthesia for implant of a long-term device or heart transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2010 (estimated)
- Study startJun 2009
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 0 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, Thoratec Corporation/Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171950
- Sponsor's protocol ID
- PED-001
- Status last verified
- Jun 2022
- First submitted
- 27 Jul 2010
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CentriMag Ventricular Assist System (VAS): Treatment of Failure-to-Wean From Cardiopulmonary Bypass for Pediatric Patients
- ClinicalTrials.gov ID
- NCT01171950
- Acronym / sponsor ID
- PED-001
- Conditions
- Heart Failure
- Keywords
- Thoratec Corporation
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- Thoratec Corporation
- Study start
- Jun 2009
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 29 Jul 2010 (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.
The purpose of the study is to evaluate the safety and effectiveness of the CentriMag ventricular assist system to help pediatric 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 |
|---|---|---|
| All Patients | Other | Device: CentriMag Ventricular Assist SystemAll patients meeting the patient selection criteria will be treated with the CentriMag device. |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 5 years to 16 years, inclusive
- Inability to wean from cardiopulmonary bypass (CPB)
Key exclusion criteria (10 listed)
- Body weight < 20 kg
- Severe aortic insufficiency
- Unrestricted intra-cardiac communications (i.e. large VSD)
- Pulmonary vascular resistance index (PVRI) > 10 IU
- Presence of DIC
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 patients will be treated with the CentriMag device for up to 30 days. | Device | All Patients |
Primary outcome
Survival
Time frame: 30 days after device removal, or, induction of anesthesia for implant of a long-term device or heart transplant
In patients who recover and do not go on to transplantation or a long-term device: • Survival 30 days after removal of the CentriMag VAS or to discharge, whichever is longer. In patients who do not recover: • Ability to be removed from the CentriMag VAS and survive to induction of anesthesia for implantation of a long-term device or heart transplantation.
1 secondary outcome
Evaluation of end-organ function
Time frame: 30 days after device removal, or, to induction of anesthesia for implant of a long-term device or heart transplant
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
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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
Thoratec Corporation/Abbott
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.
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 2 inclusion and 10 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: withdrawn, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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 after device removal, or, induction of anesthesia for implant 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 24 Jun 2022.