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.
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.
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.
Parallel
DragonFly System
DeviceThis group is allocated to use DragonFly System for edge-to-edge repair manufactured by Hangzhou Valgen Medtech Co., Ltd.
Drug
DrugThis group will continue to be managed on medical therapy, per physician discretion
Clinical success at 12 months after the procedure
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.
Mitral regurgitation severity
Percentage of patients with mitral regurgitation of 2+ or less.
Recurrent heart failure (HF) hospitalizations
Number of patients with incidence of re-hospitalizations for heart failure after Dragonfly implantation.
NYHA Class
Number of patients with New York Heart Association (NYHA) Function Class I or II.
Change in 6 minutes walk test distance
Improvement in 6 Minute Walk Test distance at 12 months over baseline.
Incidence of adverse events
MAE is defined as a combined clinical endpoint of single leaflet device attachment (SLDA), device embolization, endocarditis requiring surgery, mitral stenosis confirmed by the echocardiographic core laboratory requiring surgical intervention, left ventricular assist device (LVAD) implantation, heart transplantation, and nonelective cardiovascular surgery for device or procedure-related adverse events occurring after transseptal catheterization.（only for experimental group）
Incidence of major adverse events (MAEs)
MAE is defined as a combined clinical endpoint of death, stroke, myocardial infarction, and nonelective cardiovascular surgery for device or procedure-related adverse events occurring after transseptal catheterization.（only for experimental group）
All-cause mortality
Percentage of all-cause death includes cardiac death, non-cardiac death, and death from unknown causes.
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