Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06605313
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
SQ-Kyrin-T First-in-man Feasibility Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
First-in-man Feasibility Study of SQ-Kyrin-T Transcatheter Tricuspid Valve Clip Delivery System and Steerable Guide Catheter in Patients With Severe Tricuspid Regurgitation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to evaluate the performance operability and reliability of the SQ-Kyrin-T Transcatheter Edge-to Edge Valve Repair System in treating severe tricuspid regurgitation in Chinese population with high or prohibitive risk for conventional surgery and to provide safety and efficacy data on which subsequent confirmatory trial can be based
Detailed Description:
A prospective multicenter single-arm feasibility trial to evaluate the performance operability and reliability of the SQ-Kyrin-T Transcatheter Edge-to Edge Valve Repair System in treating severe tricuspid regurgitation in Chinese population with high or prohibitive risk for conventional surgery
It plans to enroll 12 qualified patients The primary endpoint of the study is the postoperative technical success rate Patients will be seen for follow-up visits at discharge 30 days 6 months and annually through 5 years
It plans to enroll 12 qualified patients The primary endpoint of the study is the postoperative technical success rate Patients will be seen for follow-up visits at discharge 30 days 6 months and annually through 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None