Cardiopulmonary BypassBARTNCT05473130
Breethe Abiomed Recovery RegisTry (BART)
An observational study of Cardiopulmonary Bypass and ARDS, run by Abiomed Inc. at 6 sites in United States.
Trial summary
The BART Registry intended to utilize observational data of the Abiomed Breethe OXY-1 System™ in real-world settings to drive best practice usage patterns, serve as a tool to measure and improve the quality of patient care and as a resource to inform us on the design of future studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiopulmonary Bypass, ARDS, Heart Failure
- What is being tested?
- Breethe Oxy-1 System
- Type of treatment
- Medical device
- How many people
- 48 participants
- Where
- 6 sitesUnited States
- Study dates
- 31 Mar 2021to 2 Apr 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: Subjects supported with Breethe Oxy-1 System
Who may be able to join
- all adult subjects supported with Breethe Oxy-1 System
Who cannot join
- subjects under 18 years of age
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Emory University
Atlanta, Georgia, 30322
University of Maryland
College Park, Maryland, 20742
Baylor College of Medicine
Houston, Texas, 77030
NYU School of Medicine
New York, New York, 10016
AdventHealth Orlando
Orlando, Florida, 32803
UPenn Health System
Philadelphia, Pennsylvania, 19104
About this study
The BART Registry intended to utilize observational data of the Abiomed Breethe OXY-1 System™ in real-world settings to drive best practice usage patterns, serve as a tool to measure and improve the quality of patient care and as a resource to inform us on the design of future studies.
- Conditions
- Cardiopulmonary Bypass, ARDS, Heart Failure
- Being tested
- Breethe Oxy-1 System
- Keywords
- Breethe Oxy-1 System, Extracorporeal Membrane Oxygenation, Cardiopulmonary bypass, ARDS, Heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breethe Oxy-1 SystemDevice
To pump, oxygenate, and remove carbon dioxide from blood during cardiopulmonary bypass with Breethe Oxy-1 System
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival up to the hospital discharge
Measured: Up to the hospital discharge, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start31 Mar 2021
- Primary completion2 Apr 2024
- Study completion2 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary BypassStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abiomed Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473130
- Sponsor's protocol ID
- 11202020
- Acronym
- BART
- Status last verified
- Jul 2024
- First submitted
- 15 Feb 2022
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breethe Abiomed Recovery RegisTry (BART)
- ClinicalTrials.gov ID
- NCT05473130
- Acronym / sponsor ID
- BART / 11202020
- Conditions
- Cardiopulmonary Bypass, ARDS, Heart Failure
- Keywords
- Breethe Oxy-1 System, Extracorporeal Membrane Oxygenation, Cardiopulmonary bypass, ARDS, Heart failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Abiomed Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 2 Apr 2024 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 25 Jul 2022 (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 BART Registry intended to utilize observational data of the Abiomed Breethe OXY-1 System™ in real-world settings to drive best practice usage patterns, serve as a tool to measure and improve the quality of patient care and as a resource to inform us on the design of future studies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects supported with Breethe Oxy-1 System
Key inclusion criteria (1 listed)
- all adult subjects supported with Breethe Oxy-1 System
Key exclusion criteria (1 listed)
- subjects under 18 years of age
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 |
|---|---|---|
| Breethe Oxy-1 SystemTo pump, oxygenate, and remove carbon dioxide from blood during cardiopulmonary bypass with Breethe Oxy-1 System | Device | – |
Primary outcome
Survival up to the hospital discharge
Time frame: Up to the hospital discharge, an average of 2 months
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 4 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiopulmonary Bypass and ARDS, run by Abiomed Inc. at 6 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 1 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 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 up to the hospital discharge (time frame: Up to the hospital discharge, an average of 2 months). 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 4 Sep 2024.