RecruitingNot ApplicableNCT05927441

DragonFly EU Pivotal Study

Safety and Performance Evaluation Study of DragonFly System for Mitral Regurgitation

Sponsor

Hangzhou Valgen Medtech Co., Ltd

Enrollment

168 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Mitral Valve Insufficiency

Summary

To confirm the effectiveness and safety of the DragonFly Transcatheter Mitral Valve Repair System for the treatment of symptomatic moderate-to-severe (3+) or severe (4+) degenerative mitral regurgitation in high surgical risk subjects and symptomatic moderate-to- severe (3+) or severe (4+) functional mitral regurgitation subjects who remained clinically symptomatic after adequate treatment.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called DragonFly Transcatheter Mitral Valve Repair System for people with mitral valve insufficiency. 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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