Mitral Regurgitation Functional
Conditions
Brief 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.
Detailed description
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.
Interventions
DEVICEDragonFly System
This group is allocated to use DragonFly System for edge-to-edge repair manufactured by Hangzhou Valgen Medtech Co., Ltd.
DRUGDrug
This group will continue to be managed on medical therapy, per physician discretion
Sponsors
Hangzhou Valgen Medtech Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 6 minutes walk test distance | 12 months | Improvement in 6 Minute Walk Test distance at 12 months over baseline. |
| Left Ventricular End Diastolic Volume (LVEDV) | 12 months | Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE). |
| Acute procedural success（only for experimental group） | Immediately after procedure, Discharge: The day after the patient's exit from the cardiac catheterization laboratory | 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. |
| Acute device success（only for experimental group） | Immediately after procedure | 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. |
| Mitral regurgitation severity | 30 days, 6 months, 12 months | Percentage of patients with mitral regurgitation of 2+ or less. |
| Recurrent heart failure (HF) hospitalizations | 30 days, 6 months, 12 months | Number of patients with incidence of re-hospitalizations for heart failure after Dragonfly implantation. |
| NYHA Class | 30 days, 6 months, and 12 months | Number of patients with New York Heart Association (NYHA) Function Class I or II. |
| Quality of life improvement | 12 months | Improvement in quality of life (QoL) at 12 months over baseline, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | 12 months | 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） |
| All-cause mortality | 12 months | Percentage of all-cause death includes cardiac death, non-cardiac death, and death from unknown causes. |
| Incidence of major adverse events (MAEs) | 30 Days | 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） |
Countries
China
Contacts
Primary ContactBo Liu
Backup ContactXiaoxu Yang
Outcome results
None listed