Breethe Abiomed Recovery regisTry (BART)
Sponsor
Abiomed Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05473130
Collaborator
(none)
1,000
6
56.3
166.7
3
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
1000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Breethe Abiomed Recovery regisTry (BART)
Actual Study Start Date
:
Mar 31, 2021
Anticipated Primary Completion Date
:
Dec 9, 2025
Anticipated Study Completion Date
:
Dec 9, 2025
Outcome Measures
Primary Outcome Measures
- Survival up to the hospital discharge [Up to the hospital discharge, an average of 2 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- all adult subjects supported with Breethe Oxy-1 System
Exclusion Criteria:
- subjects under 18 years of age
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | AdventHealth Orlando | Orlando | Florida | United States | 32803 |
| 2 | Emory University | Atlanta | Georgia | United States | 30322 |
| 3 | University of Maryland | College Park | Maryland | United States | 20742 |
| 4 | NYU School of Medicine | New York | New York | United States | 10016 |
| 5 | UPenn Health System | Philadelphia | Pennsylvania | United States | 19104 |
| 6 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Abiomed Inc.
Investigators
- Study Director: Amin Medjamia, MD, Abiomed Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Abiomed Inc.
ClinicalTrials.gov Identifier:
NCT05473130
Other Study ID Numbers:
- 11202020
First Posted:
Jul 25, 2022
Last Update Posted:
Jul 25, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Abiomed Inc.
Additional relevant MeSH terms: