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RECRUITING
NCT06823700
NA

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

Sponsor: Shanghai Shenqi Medical Technology Co., Ltd

View on ClinicalTrials.gov

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

Interventions

DEVICE

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