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

NCT06823700 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-02-12

No results posted yet for this study

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.

Conditions

  • Functional Mitral Regurgitation

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.

Sponsors & Collaborators

  • Shanghai Shenqi Medical Technology Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Ignacio J Amat-Santos, MD, Ph.D · Hospital Clínico Universitario de Valladolid

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-17
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06823700 on ClinicalTrials.gov