Breethe Abiomed Recovery RegisTry (BART)

NCT ID: NCT05473130

Last Updated: 2024-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-31

Study Completion Date

2024-04-02

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiopulmonary Bypass ARDS Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Breethe Oxy-1 System

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* all adult subjects supported with Breethe Oxy-1 System

Exclusion Criteria

* subjects under 18 years of age
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abiomed Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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AdventHealth Orlando

Orlando, Florida, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

University of Maryland

College Park, Maryland, United States

Site Status

NYU School of Medicine

New York, New York, United States

Site Status

UPenn Health System

Philadelphia, Pennsylvania, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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11202020

Identifier Type: -

Identifier Source: org_study_id

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