Ignite Creation Date:
2024-05-06 @ 2:58 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04483089
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-29
First Post:
2020-07-16
Brief Title:
An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip Device bRIGHT
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip Device
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
bRIGHT
Brief Summary:
The bRIGHT EU PAS study is an observational real-world study evaluating severe tricuspid regurgitation patients treated with the Abbott TriClip device bRIGHT EU Post-Approval Study
Detailed Description:
The TriClip bRIGHT EU post-approval study PAS study is designed to confirm the safety and performance of the TriClip device in a contemporary real-world setting The bRIGHT PAS study is a prospective single arm open-label multi-center post market registry conducted to satisfy condition of CE Marking for the TriClip
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None