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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
Shanghai Huihe Healthcare Tecnology Co.,Ltd.
Shanghai, Shanghai Municipality, China
RECRUITINGSuccess rate 1year after operation
Time frame: 1-year after operation
Success rate of operation
Time frame: intra-procedure
Success rate of device implantation
Time frame: intra-procedure
Change in echocardiographic parameters
Tricuspid annulus perimeter(mm)
Time frame: 30 days, 6 Months, 12 Months, annual for five years
Change in echocardiographic parameters
Tricuspid annulus area(mm2)
Time frame: 30 days, 6 Months, 12 Months, annual for five years
Change of Tricuspid Regurgitation Grade
Number of patients with reduction in TR from baseline
Time frame: 30 days, 6 Months, 12 Months, annual for five years
NYHA Functional Class
Number of patients with improvement in NYHA class
Time frame: 30 days, 6 Months, 12 Months, annual for five years
6 minutes walk distance
Increase in distance (m) from baseline
Time frame: 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
Time frame: 30 days, 6 Months, 12 Months
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