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The purpose of this clinical trial is to evaluate the effectiveness and safety of the transcatheter mitral valve repair system in the treatment of patients with moderate or above degenerative mitral regurgitation.
This study is a prospective,multi-center, single-arm, safety and performance clinical study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Transcatheter Mitral Valve Repair with Valveclip® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valveclip® Transcatheter mitral valve repair | Device | Transcatheter mitral valve repair system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of product | Efficacy of product is defined as the proportion of participants meeting effective standards after surgery (freedom from death, mitral valve reoperation or MR>2+ at 12 months). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of product | Efficacy of product is defined as the proportion of participants meeting effective standards after surgery (freedom from death, mitral valve reoperation or MR>2+ at 30 days, 180 days, 2 to 5 years). | 30 days, 180 days, 2 to 5 years |
| Rate of Cardiovascular related mortality |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | Technical success after Transcatheter Mitral Valve Repairment | immediate post-surgical |
| Device success | Device success after Transcatheter Mitral Valve Repairment |
Inclusion Criteria:
4) Left ventricular ejection fraction≥30%; 5) As assessed by multidisciplinary cardiac team (at least two cardiac surgeons/one cardiologist), patients who are at extremely high-risk or unsuitable for routine mitral valve surgery with evaluation; 6) Patients who understand the purpose of the trial and volunteer to participate in, sign the informed consent form and are willing to accept relevant examinations and clinical follow-ups.
Anatomy selection Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| chunyang Wang, CRA | Contact | (86)-21-20788668 | cywang@newmed.cn | |
| xuyang Xie | Contact | (86)-21-20788668 | xyxie@newmed.cn |
| Name | Affiliation | Role |
|---|---|---|
| mao Chen, Chief | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, West China Hospital, Sichuan University | Recruiting | Sichuan | China |
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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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Cardiovascular related mortality after Transcatheter Mitral Valve Repairment |
| 30 days, 180 days, 1 year, 2 to 5 years |
| Rate of Severe adverse events | Severe adverse events after Transcatheter Mitral Valve Repairment (including death, stroke, myocardial infarction, reoperation, instrumental non-selective cardiovascular surgery, renal failure, and adverse events related to transfemoral vein septal approach surgery, etc.) | 30 days, 180 days, 1 year, 2 to 5 years |
| Quality of life Improvement | The 12-Item Short-Form Health Survey(SF-12) | 30 days, 180 days, 1 year, 2 to 5 years |
| 30 days、180 days、1 year |
| Procedural success | Procedural success after Transcatheter Mitral Valve Repairment | 30 days |