Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT04936802
Status:
UNKNOWN
Last Update Posted:
2021-06-23
First Post:
2021-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Feasibility of the Transcatheter Tricuspid Valve Repair System (Trialign)
Sponsor:
Xijing Hospital
Organization:
Study Overview
Official Title:
Safety and Feasibility of the Transcatheter Tricuspid Valve Repair System (Trialign) for the Treatment or Reduction of Moderate to Severe Functional Tricuspid Regurgitation
Status:
UNKNOWN
Status Verified Date:
2021-06
Last Known Status:
NOT_YET_RECRUITING
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:
None
Brief Summary:
The purpose of the study is to demonstrate safety and feasibility of the transcatheter tricuspid valve repair system (Trialign) for the treatment or reduction of moderate to severe functional tricuspid regurgitation.
Detailed Description:
This study is a prospective single-arm trial for transcatheter tricuspid valve repair system (Trialign). A series of physical, imaging and laboratory exams will be performed to determine whether a subject has moderate to severe tricuspid regurgitation with high surgical risk. Subjects who meet the criteria will then receiveTrialign treatment if an informed consent is obtained.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: