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CompletedNCT05473130BARTUpdated Sep 4, 2024

Breethe Abiomed Recovery RegisTry (BART)

An observational study in Cardiopulmonary Bypass, ARDS and Heart Failure, sponsored by Abiomed Inc.. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-04.

Sponsored by Abiomed Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
48
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Cardiopulmonary Bypass
  • ARDS
  • Heart Failure

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Keywords

  • Breethe Oxy-1 System
  • Extracorporeal Membrane Oxygenation
  • Cardiopulmonary bypass
  • ARDS
  • Heart failure
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In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 48 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Abiomed Inc. is the lead sponsor of 33 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects supported with Breethe Oxy-1 System

Inclusion criteria

  • all adult subjects supported with Breethe Oxy-1 System

Exclusion criteria

Exclusion Criteria:

  • subjects under 18 years of age
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
48 participants (actual)
Patient registry
No

Interventions

  • DeviceBreethe Oxy-1 System

    To pump, oxygenate, and remove carbon dioxide from blood during cardiopulmonary bypass with Breethe Oxy-1 System

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What researchers measure

Primary outcomes

  1. Survival up to the hospital discharge

    Time frame: Up to the hospital discharge, an average of 2 months

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Study locations

6 sites
  • AdventHealth Orlando
    Orlando, Florida 32803, United States
  • Emory University
    Atlanta, Georgia 30322, United States
  • University of Maryland
    College Park, Maryland 20742, United States
  • NYU School of Medicine
    New York, New York 10016, United States
  • UPenn Health System
    Philadelphia, Pennsylvania 19104, United States
  • Baylor College of Medicine
    Houston, Texas 77030, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05473130
Lead sponsor
Abiomed Inc.
Responsible party
Sponsor
First posted
Jul 25, 2022
Start date
Mar 31, 2021
Primary completion
Apr 2, 2024
Completion
Apr 2, 2024
Last update
Sep 4, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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