Heart FailureNCT04464785
CentriMag Failure-to-Wean Post Approval Study
An observational study of Heart Failure, run by Abbott Medical Devices at 8 sites in United States.
Trial summary
The primary objective of this Post Approval Study is to report the proportion of patients surviving to 30 days post CentriMag support or to hospital discharge, whichever is longer. 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 Circulatory Support System
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 8 sitesUnited States
- Study dates
- 30 Dec 2020to 25 Oct 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female subjects who fail-to-wean from cardiopulmonary bypass.
Who may be able to join
- Subject >18 years of age
- Subject or legal representative has signed Informed Consent Form (ICF)
- Subject has CentriMag Circulatory Support System implanted due to Failure To Wean from Cardiopulmonary Bypass
Who cannot join
- Concomitant use of Extracorporeal Membrane Oxygenation (ECMO) during CentriMag Circulatory Support System implantation due to FTW from CPB
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Michigan
Ann Arbor, Michigan, 48104
Emory University Hospital
Atlanta, Georgia, 30322
Baptist Healt Medical Center
Little Rock, Arkansas, 72205
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, 55455
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
University of Utah
Salt Lake City, Utah, 84132
Barnes Jewish Hospital
St Louis, Missouri, 63110
About this study
Official title: CentriMag Failure-to-Wean Post-Approval Study
The primary objective of this Post Approval Study is to report the proportion of patients surviving to 30 days post CentriMag support or to hospital discharge, whichever is longer. For subjects who do not recover and are bridged to a heart transplant or a long-term assist device, the primary endpoint is survival to induction of anesthesia for the surgery.
- Conditions
- Heart Failure
- Being tested
- CentriMag Circulatory Support System
- 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 Circulatory Support SystemDevice
The CentriMag Circulatory Suppose System is indicated for providing support for up to 30 days for one or both ventricles of the heart to treat post-cardiotomy patients who fail-to-wean from cardiopulmonary bypass, providing a bridge to decision when it is unclear whether the patient's heart will recover or whether the patient will need alternative, longer-term therapy.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Subjects who receive the CentriMag Circulatory Support System Receives: Device: CentriMag Circulatory Support System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival to 30 days Post CentriMag support or to hospital discharge
The proportion of subjects who survive to 30 days post CentriMag support or to hospital discharge (whichever is longer).
Measured: 30 days
Survival to induction of anesthesia for surgery for transplant or a long-term system
The proportion of subjects who do not recover and are bridged to a transplant or long-term system
Measured: Approximately 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start30 Dec 2020
- Primary completion25 Oct 2024
- Study completion25 Oct 2024
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Crowe, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04464785
- Sponsor's protocol ID
- ABT-CIP-10336
- Status last verified
- Dec 2024
- First submitted
- 7 Jul 2020
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CentriMag Failure-to-Wean Post-Approval Study
- ClinicalTrials.gov ID
- NCT04464785
- Acronym / sponsor ID
- ABT-CIP-10336
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- 25 Oct 2024 (actual)
- Study completion
- 25 Oct 2024 (actual)
- First posted
- 9 Jul 2020 (actual)
- 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 primary objective of this Post Approval Study is to report the proportion of patients surviving to 30 days post CentriMag support or to hospital discharge, whichever is longer. For subjects who do not recover and are bridged to a heart transplant or a long-term assist device, the primary endpoint is survival to induction of anesthesia for the surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Device: CentriMag Circulatory Support SystemSubjects who receive the CentriMag Circulatory Support System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female subjects who fail-to-wean from cardiopulmonary bypass.
Key inclusion criteria (3 listed)
- Subject >18 years of age
- Subject or legal representative has signed Informed Consent Form (ICF)
- Subject has CentriMag Circulatory Support System implanted due to Failure To Wean from Cardiopulmonary Bypass
Key exclusion criteria (1 listed)
- Concomitant use of Extracorporeal Membrane Oxygenation (ECMO) during CentriMag Circulatory Support System implantation due to FTW from CPB
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 Circulatory Support SystemThe CentriMag Circulatory Suppose System is indicated for providing support for up to 30 days for one or both ventricles of the heart to treat post-cardiotomy patients who fail-to-wean from cardiopulmonary bypass, providing a bridge to decision when it is unclear whether the patient's heart will recover or whether the patient will need alternative, longer-term therapy. | Device | Treatment |
Primary outcome
Survival to 30 days Post CentriMag support or to hospital discharge
Time frame: 30 days
The proportion of subjects who survive to 30 days post CentriMag support or to hospital discharge (whichever is longer).
Survival to induction of anesthesia for surgery for transplant or a long-term system
Time frame: Approximately 30 days
The proportion of subjects who do not recover and are bridged to a transplant or long-term system
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Brian Crowe study director
Abbott
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Abbott Medical Devices at 8 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 3 inclusion and 1 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 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 to 30 days Post CentriMag support or to hospital discharge (time frame: 30 days). The study lists 2 primary outcomes in all. 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 11 Dec 2024.