Mitral Valve (MV) Regurgitation
Conditions
Brief summary
To confirm the effectiveness and safety of the DragonFly M2 Transcatheter Mitral Valve Repair System for the treatment of symptomatic moderate-to-severe (3+) or severe (4+) degenerative mitral regurgitation in high surgical risk subjects.The safety and effectiveness of the first-generation device(Dragonfly Transcatheter Mitral Valve Repair System)have been previously demonstrated. This study aims to further confirm the safety and effectiveness of the new device following structural optimization based on the first-generation design.
Detailed description
This is a prospective, multicentric clinical investigation. Subjects to be included in this clinical investigation suffer from symptomatic chronic moderate-to-severe (3+) or severe (4+) DMR with high or prohibitive surgical risk judged by a local investigation site's heart team . After signing an informed consent form, subjects in the experimental group will undergo the transcatheter mitral valve repair procedure using the DragonFly M2 Transcatheter Mitral Valve Clip System. All subjects were followed up immediately after procedure, before discharge, 30 days , 6 months, 12 months after procedure, and 2, 3, 4, and 5 years after procedure.
Interventions
DEVICEDragonFly M2 Transcatheter Mitral Valve Repair System
Edge-to-edge repair with DragonFly M2 System
Sponsors
Hangzhou Valgen Medtech Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1.≥ 18 years old. 2.Moderate to severe (3+) or severe (4+) chronic DMR determined by transthoracic echocardiography. * Transseptal catheterization is determined to be feasible by the Investigator. * Patients have been informed of the nature of the study, understand the purpose of the clinical trial, voluntarily participate in the study, and sign the ICF.
Exclusion criteria
1)Echocardiographic evidence of intracardiac mass, thrombus, or vegetation. 2) The presence of other severe heart valve disease requiring surgical intervention. 3\) Prior mitral valve leaflet surgery or transcatheter mitral valve 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 |
|---|---|---|
| Procedure success | 30 Days | Procedure success: device implanted successfully, MR ≤ 2+ at discharge (or 30-day echo if unavailable), and no death or device-related reintervention within 30 days post-procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute device success | 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. |
| surgical intervention | 30 days, 6 months, and 12 months | surgical interventions due to post-procedural mitral valve dysfunction |
| 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 | 30 days, 6 months, and 12 months | Improvement in quality of life (QoL) over baseline, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). |
| Single-click release success | Intraoperative | successful clip detachment from the delivery system at the intended position during the first release attempt |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular death | 30 Days, 6 months, 12 months | Cardiovascular death |
| All-cause mortality | 30 days, 6 months, and 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, 6 months, and 12 months | MAE is defined as a combined clinical endpoint of death, stroke, myocardial infarction, renal failure, and nonelective cardiovascular surgery for device or procedure-related adverse events occurring after transseptal catheterization. |
Countries
China
Contacts
Primary ContactBo Liu
Backup ContactXiaoxu Yang
Outcome results
None listed