Breethe Abiomed Recovery regisTry (BART)

Suspended

• Conditions: Heart Failure; Cardiopulmonary Bypass; ARDS

• Registration Number: NCT05473130
• Lead Sponsor: Abiomed Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-31
• Study First Submitted: 2022-02-15
• Study First Submitted QC: 2022-07-22
• Study First Posted: 2022-07-25
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-24
• Primary Completion: 2025-12-09
• Study Completion: 2025-12-09

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• all adult subjects supported with Breethe Oxy-1 System

Exclusion Criteria

• subjects under 18 years of age

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival up to the hospital discharge	Up to the hospital discharge, an average of 2 months