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Safety and Effectiveness Study of SQ-Kyrin System for Functional Mitral Regurgitation in EU
Sponsor: Shanghai Shenqi Medical Technology Co., Ltd
Summary
The investigation objective of this study is to evaluate the safety and effectiveness of the Transcatheter Mitral Valve Clip Delivery System and Steerable Guide Catheter in the population of FMR patients and the accessories devices when used in conjunction with the Transcatheter Mitral Valve Clip Delivery System and Steerable Guide Catheter.
Official title: A Prospective, Multicenter, Single Arm Study to Evaluate the Safety and Effectiveness of Shenqi Transcatheter Mitral Valve Clips Delivery System and Steerable Guide Catheters in Patients with Functional Mitral Regurgitation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
34
Start Date
2024-12-17
Completion Date
2026-12-31
Last Updated
2025-02-12
Healthy Volunteers
No
Conditions
Interventions
SQ-Kyrin Transcatheter Mitral Valve Repair System
To percutaneously repair the mitral valve via the femoral vein and atrial septum, offering a treatment for symptomatic functional mitral regurgitation through edge-to-edge valve clipping.
Locations (1)
Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, Spain