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Evaluate the effectiveness and safety of the transcatheter tricuspid annuloplasty system manufactured by Shanghai Huihe Medical Technology Co., Ltd. for the treatment of patients with moderate-severe or worse tricuspid regurgitation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| K-clipTM transcatheter annuloplasty system | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter Annuloplasty | Device | Under echocardiography guidance, the transcatheter tricuspid annuloplasty system precisely reaches the specified position in the tricuspid valve region via jugular vein and superior vena cava approach. The enlarged tricuspid annular tissue is clamped with the clamp cpart and anchor part to reduce the perimeter of tricuspid annulus, so that the area of tricuspid orifice that could not be coapted is reduced. It plays the purpose of minimally invasive treatment of tricuspid valve. |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate 1year after operation | 1-year after operation | |
| Success rate of operation | intra-procedure | |
| Success rate of device implantation | intra-procedure | |
| Change in echocardiographic parameters | Tricuspid annulus perimeter(mm) | 30 days, 6 Months, 12 Months, annual for five years |
| Change in echocardiographic parameters | Tricuspid annulus area(mm2) | 30 days, 6 Months, 12 Months, annual for five years |
| Change of Tricuspid Regurgitation Grade | Number of patients with reduction in TR from baseline | 30 days, 6 Months, 12 Months, annual for five years |
| NYHA Functional Class | Number of patients with improvement in NYHA class | 30 days, 6 Months, 12 Months, annual for five years |
| 6 minutes walk distance | Increase in distance (m) from baseline | 1 month, 6 months,12 Months |
| Kansas City Cardiomyopathy Questionnaire | Number of points of improvement in health status as measured by Kansas City Cardiomyopathy Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sally Yan, project supervisor | Contact | 18800263183 | Sally.yan@hh-healthcare.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Huihe Healthcare Tecnology Co.,Ltd. | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 30 days, 6 Months, 12 Months |