Breethe Abiomed Recovery RegisTry (BART) | NCT05473130

Studies
Breethe Abiomed Recovery RegisTry (BART)

NCT05473130

Sponsor

Abiomed Inc.

Status

Completed

Last Update Posted

Sep 4, 2024Actual

Enrollment

48Actual

Phase

Not provided

Conditions

Cardiopulmonary Bypass
ARDS
Heart Failure

Interventions

Breethe Oxy-1 System

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 31, 2021Actual

Primary Completion Date

Apr 2, 2024Actual

Completion Date

Apr 2, 2024Actual

First Submitted Date

Feb 15, 2022

First Submission Date that Met QC Criteria

Jul 22, 2022

First Posted Date

Jul 25, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 30, 2024

Last Update Posted Date

Sep 4, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Breethe Oxy-1 System	Device	To pump, oxygenate, and remove carbon dioxide from blood during cardiopulmonary bypass with Breethe Oxy-1 System

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survival up to the hospital discharge		Up to the hospital discharge, an average of 2 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all adult subjects supported with Breethe Oxy-1 System

Exclusion Criteria:

subjects under 18 years of age

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects supported with Breethe Oxy-1 System

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AdventHealth Orlando		Orlando	Florida	32803	United States
Emory University

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided