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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized - Device Group | Experimental | This group is allocated to use DragonFly System for edge-to-edge repair manufactured by Hangzhou Valgen Medtech Co., Ltd. |
|
| Randomized - Control Group | Active Comparator | This group will continue to be managed on medical therapy, per physician discretion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DragonFly System | Device | This group is allocated to use DragonFly System for edge-to-edge repair manufactured by Hangzhou Valgen Medtech Co., Ltd. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mitral regurgitation severity | Percentage of patients with mitral regurgitation of 2+ or less. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Inclusion Criteria:
1) Age ≥ 18 yrs. 2) Symptomatic functional mitral regurgitation (FMR) (≥3+) due to ischemic or non-ischemic cardiomyopathy
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bo Liu | Contact | +86 13001980902 | bo.liu@valgenmed.com | |
| Xiaoxu Yang | Contact | +86 18910330079 | xiaoxu.yang@valgenmed.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianan Wang | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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| Drug | Drug | This group will continue to be managed on medical therapy, per physician discretion |
|
| 30 days, 6 months, 12 months |
| NYHA Class | Number of patients with New York Heart Association (NYHA) Function Class I or II. | 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. | 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). | 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). | 12 months |
| 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. | 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. | Immediately after procedure |
| 12 months |
| 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) | 30 Days |
| All-cause mortality | Percentage of all-cause death includes cardiac death, non-cardiac death, and death from unknown causes. | 12 months |