DragonFly System: This group is allocated to use DragonFly System for edge-to-edge repair manufactured by Hangzhou Valgen Medtech Co., Ltd.
Drug: This group will continue to be managed on medical therapy, per physician discretion
Study summary
To confirm the effectiveness and safety of the Dragonfly transcatheter mitral valve repair system for the treatment of chronic moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically symptomatic after adequate treatment.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1\) Age ≥ 18 yrs. 2) Symptomatic functional mitral regurgitation (FMR) (≥3+) due to ischemic or non-ischemic cardiomyopathy
* Transseptal catheterization and femoral vein access is determined to be feasible.
* The subject or subject's legal representative has been informed of the nature of the trial, willing to accept the experimental tests, and has provided written informed consent.
Exclusion Criteria:
1\) Echocardiographic evidence of intracardiac mass, thrombus, or vegetation. 2)Echocardiography revealed severe restriction of leaflet motion due to tethering.
3\) The presence of other severe heart valve disease requiring surgical intervention.
* Currently participating in an investigational drug or another device study that has not completed its primary endpoints or would clinically interfere with the endpoint of this study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
* In the judgment of the investigator, subjects may not complete the trial according to poor compliance or in other circumstances when the investigator determines that the subject is unfit to participate in the study.
Primary outcome measure(s)
Clinical success at 12 months after the procedure — 12 months The rate of the composite endpoint of freedom from all-cause mortality, hospitalization for heart failure, NYHA improved \<1 class and MR \> 2+ at 12 months.
Trial sites (1)
Facility
City
Region
Status
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou
Zhejiang
More Hangzhou Valgen Medtech Co., Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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