RecruitingNot ApplicableNCT06823700

Safety and Effectiveness Study of SQ-Kyrin System for Functional Mitral Regurgitation in EU

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

Sponsor

Shanghai Shenqi Medical Technology Co., Ltd

Enrollment

34 participants

Start Date

Dec 17, 2024

Study Type

INTERVENTIONAL

Conditions

Functional Mitral Regurgitation

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called SQ-Kyrin Transcatheter Mitral Valve Repair System for people with functional mitral regurgitation. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESQ-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.