Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
Study NCT ID:
NCT05486832
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2022-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Performance of the Cardiovalve TR Replacement System
Sponsor:
Cardiovalve Ltd.
Organization:
Study Overview
Official Title:
Safety and Performance of the Cardiovalve TR Replacement System for Tricuspid Regurgitation
Status:
RECRUITING
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:
TARGET
Brief Summary:
The objective of this study is to evaluate the safety and performance of Cardiovalve TR system
Detailed Description:
The study is a multi-center, prospective, single arm study designed to evaluate the safety and performance of the Cardiovalve Tricuspid Valve Replacement System
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: