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The clinical trial study is designed as a prospective, multicenter, single-group target value clinical study to evaluate the safety and efficacy of the clinical investigational product and to evaluate its performance using the above clinical trial primary endpoint and secondary endpoint indicators.
Transcatheter mitral valve repair system is derived from the "Edge-to-Edge" technique in traditional surgery. The principle is roughly to clamp the midpoint of the anterior leaflet and the midpoint of the posterior leaflet of the mitral valve to form a double-hole inflow channel and then improve the regurgitation.Using the JensClip transcatheter valve repair system for the treatment of patients with moderate-severe or severe degenerative mitral regurgitation who are at high surgical risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JensClip transcatheter valve repair system | Experimental | Using the JensClip transcatheter valve repair system for the treatment of patients with moderate-severe or severe degenerative mitral regurgitation who are at high surgical risk. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JensClip transcatheter valve repair system | Device | Transcatheter mitral valve repair system is derived from the "Edge-to-Edge" technique in traditional surgery. The principle is roughly to clamp the midpoint of the anterior leaflet and the midpoint of the posterior leaflet of the mitral valve to form a double-hole inflow channel and then improve the regurgitation. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical success rate at 12 months postoperatively | Clinical success is defined as no death, no mitral valve-related surgical procedures due to mitral valve incompetence, and no moderate-severe or severe mitral regurgitation (MR > 2+), with the primary evaluation indicators determined by the Core Laboratory and Clinical Event Committee (CEC). | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shengshou Hu | Contact | 18616900716 | guyongxin@jenscare.com |
| Name | Affiliation | Role |
|---|---|---|
| Shengshou Hu | FUWAI YUNAN CARDIOVASCULAR HOSPITAL | Principal Investigator |
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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