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Safety and Effectiveness Study of SQ-Kyrin TMVr System for Degenerated Mitral Regurgitation
Sponsor: Shanghai Shenqi Medical Technology Co., Ltd
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).
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
118
Start Date
2021-10-15
Completion Date
2028-12-15
Last Updated
2024-06-20
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
General Hospital of Northern Theater Command, PLA
Shenyang, Liaoning, China