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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DragonFly M2 Transcatheter Mitral Valve Repair System | Experimental | Transcatheter mitral valve repair with the DragonFly M2 System in patients with degenerative mitral regurgitation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DragonFly M2 Transcatheter Mitral Valve Repair System | Device | Edge-to-edge repair with DragonFly M2 System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procedure success | 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. | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Single-click release success | successful clip detachment from the delivery system at the intended position during the first release attempt | Intraoperative |
| Acute device success | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of major adverse events (MAEs) | 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. | 30 days, 6 months, and 12 months |
| All-cause mortality |
Inclusion Criteria:
1.≥ 18 years old. 2.Moderate to severe (3+) or severe (4+) chronic DMR determined by transthoracic echocardiography.
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bo Liu | Contact | +86 13001980902 | bo.liu@valgenmed.com | |
| Xiaoxu Yang | Contact | +8618910330079 | xiaoxu.yang@valgenmed.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiangbin Pan | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital Chinese Academy of Medical Sciences | Shenzhen | Guangdong | 518000 | China |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Immediately after procedure |
| surgical intervention | surgical interventions due to post-procedural mitral valve dysfunction | 30 days, 6 months, and 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 |
| Quality of life improvement | Improvement in quality of life (QoL) over baseline, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). | 30 days, 6 months, and 12 months |
Percentage of all-cause death includes cardiac death, non-cardiac death, and death from unknown causes. |
| 30 days, 6 months, and 12 months |
| Cardiovascular death | Cardiovascular death | 30 Days, 6 months, 12 months |
| D004066 | Digestive System Diseases |