Breethe Abiomed Recovery RegisTry (BART)

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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Key information

Conditions

Cardiopulmonary Bypass ARDS Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AdventHealth Orlando, Orlando, Florida, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

all adult subjects supported with Breethe Oxy-1 System

Exclusion criteria

subjects under 18 years of age

Treatment and study plan

Breethe Oxy-1 System

Device

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

Primary outcomes

Survival up to the hospital discharge

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

Sponsors and collaborators

Lead sponsor

Abiomed Inc.

Industry

Registry information

Acronym: BART

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2024
First posted: Jul 25, 2022
Registry last updated: Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting