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.
This study is a prospective, multicenter, randomized controlled design. Patients are chronic moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically symptomatic after guideline-directed medical treatment. After signing an informed consent form, subjects in the experimental group will undergo the transcatheter mitral valve repair procedure using the DragonFly™ Transcatheter Mitral Valve Clip System . According to the investigator's discretion, all subjects in the treatment group will continue to receive maximally tolerated guideline-directed medical therapy (GDMT). Subjects in the control group will also continue maximally tolerated GDMT as determined by the investigator. After completing the 12-month follow-up, crossover to the treatment group will be permitted. All subjects were followed up before discharge (excluding the control group), and 30 days, 6 months, 12 months, and 24 months after treatment. Subjects in the experimental group and those who crossed over to the experimental group underwent extended clinical follow-up for 3, 4, and 5 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
148
This group is allocated to use DragonFly System for edge-to-edge repair manufactured by Hangzhou Valgen Medtech Co., Ltd.
This group will continue to be managed on medical therapy, per physician discretion
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
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.
Time frame: 12 months
Mitral regurgitation severity
Percentage of patients with mitral regurgitation of 2+ or less.
Time frame: 30 days, 6 months, 12 months
Recurrent heart failure (HF) hospitalizations
Number of patients with incidence of re-hospitalizations for heart failure after Dragonfly implantation.
Time frame: 30 days, 6 months, 12 months
NYHA Class
Number of patients with New York Heart Association (NYHA) Function Class I or II.
Time frame: 30 days, 6 months, and 12 months
Change in 6 minutes walk test distance
Improvement in 6 Minute Walk Test distance at 12 months over baseline.
Time frame: 12 months
Quality of life improvement
Improvement in quality of life (QoL) at 12 months over baseline, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ).
Time frame: 12 months
Left Ventricular End Diastolic Volume (LVEDV)
Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Acute procedural success（only for experimental group）
Successful in Dragonfly implantation, and residual MR of 2+ or less at discharge. An echocardiography echocardiogram at 30 days can be accepted if the discharge image was not available or hard to interpret. A death before discharge or a re-operation of mitral valve prior to 30 days is defined as acute procedure failure.
Time frame: Immediately after procedure, Discharge: The day after the patient's exit from the cardiac catheterization laboratory
Acute device success（only for experimental group）
One or more Dragonfly devices are successfully delivered and released, edge-to-edge leaflet repair confirmed by echocardiogram, and successfully withdrawal of the delivery catheter.
Time frame: Immediately after procedure