Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2025-12-25 @ 3:16 PM
Study NCT ID:
NCT05854095
Status:
COMPLETED
Last Update Posted:
2024-02-08
First Post:
2023-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Study for Evaluation of Acute Phase Safety and Efficacy of 'Pivot Bridge' to Short-term Treat FTR
Sponsor:
Tau-MEDICAL Co., Ltd.
Organization:
Study Overview
Official Title:
The Study for Evaluation of Acute Phase Safety and Efficacy of 'Pivot Bridge' to Short-term Treat Functional Tricuspid Regurgitation : Multi-center, Open Label, Single Arm, Investigator Initiated Exploratory Pilot Study
Status:
COMPLETED
Status Verified Date:
2024-02
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:
None
Brief Summary:
evaluation of safety and efficacy of 'Pivot Bridge' to short-term treat Functional Tricuspid regurgitation
Detailed Description:
evaluation of safety and efficacy of 'Pivot Bridge' to short-term treat Functional Tri cuspid regurgitation : multi-center, open label, single arm, investigator initiated exploratory pilo t study
Study Oversight
Has Oversight DMC:
None
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?: