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NCT05473130 Clinical Trial

Breethe Abiomed Recovery regisTry (BART)

Heart Failure Clinical Trial

— BART  

Official title:
Breethe Abiomed Recovery regisTry (BART)

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT05473130
Other study ID # 11202020
Secondary ID
Status Suspended
Phase
First received
Last updated
Start date March 31, 2021
Est. completion date December 9, 2025

Study information
Verified date January 2024
Source Abiomed Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

Recruitment information / eligibility
Status Suspended
Enrollment 1000
Est. completion date December 9, 2025
Est. primary completion date December 9, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - all adult subjects supported with Breethe Oxy-1 System Exclusion Criteria: - subjects under 18 years of age

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Emory University Atlanta Georgia
United States University of Maryland College Park Maryland
United States Baylor College of Medicine Houston Texas
United States NYU School of Medicine New York New York
United States AdventHealth Orlando Orlando Florida
United States UPenn Health System Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Abiomed Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Survival up to the hospital discharge Up to the hospital discharge, an average of 2 months
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