NCT06467110

Safety and Effectiveness Study of SQ-Kyrin TMVr System for Degenerated Mitral Regurgitation

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 118 (estimated)
• Sponsor: Shanghai Shenqi Medical Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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., Ltd.in 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.

Conditions

• Degenerated Mitral Regurgitation

Interventions

Type	Name	Description
DEVICE	transcatheter mitral valve clip delivery system and steerable guide catheter (Shenqi Medical)	The principle of this product is the transcatheter interventional edge-to-edge repair technology (edge-to-edge repair). The core technology is to treat the regurgitation by edge-to-edge suturing the mitral valve. The double holes are set in the mitral valve (A2/P2 zone) or the edges in A1/P1 or A3/P3 zones are apposed and closed to treat regurgitation.

Timeline

• Start date: 2021-10-15
• Primary completion: 2024-12-15
• Completion: 2028-12-15
• First posted: 2024-06-20
• Last updated: 2024-06-20

Locations

1 site across 1 country: China