Ignite Creation Date:
2024-07-17 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06467110
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-20
First Post:
2024-06-13
Brief Title:
Safety and Effectiveness Study of SQ-Kyrin TMVr System for Degenerated Mitral Regurgitation
Sponsor:
Shanghai Shenqi Medical Technology Co Ltd
Organization:
Shanghai Shenqi Medical Technology Co Ltd
Study Overview
Official Title:
A Prospective Multicenter Single-Arm Clinical Trial to Assess the Safety and Efficacy of a Transcatheter Mitral Valve Clip Delivery System With Steerable Guide Catheter in Patients With Moderate-Severe or Severe Degenerative Mitral Regurgitation DMR
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-07
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:
To verify the safety and effectiveness of transcatheter mitral valve clip delivery system and steerable guide catheter produced by Shanghai Shenqi Medical Technology Co Ltdin patients with moderate-severe or severe degenerated mitral regurgitation DMR
Detailed Description:
This study is clinical research using a prospective multicenter single arm method to evaluate the safety and effectiveness of transcatheter mitral valve clip delivery system and steerable guide catheter transcatheter mitral valve clip delivery system and steerable guide catheter in the treatment of patients with moderate-severe 3 or severe 4 degenerated mitral regurgitation A total of 118 subjects are planned to be included in this trial All subjects are treated with transcatheter mitral valve clip delivery system and steerable guide catheter transcatheter mitral valve clip delivery system and steerable guide catheter and are followed up at 30 days 6 months and 12 months after surgery At the follow-up of 12 months after surgery the composite endpoints of no death no surgical mitral valve related surgery due to mitral valve dysfunction and no moderate-severe or severe MR MR 2 are evaluated After the follow-up of 12 months after surgery the stage statistical analysis clinical summary and application for product registration are performed
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?:
None