The study aims to evaluate the feasibility and safety of polymer artificial heart valve designed and developed by Shanghai HeartEpoch Medical technology Co. Ltd. for the treatment of the mitral valve diseases.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
device: polymer artificial heart valve mitral valve replacement
The composite incidence rate of all-cause mortality and reoperation
Time frame: 3 months
Implantation success rate
Time frame: after the operation
The improvement of 6 minutes walk testing(6MWT) from baseline
Time frame: 3months, 6months
Performance evaluation of implanted valves
Time frame: 1 day after operation, 7 days after operation, 1 months after operation, 3 months after operation.
The improvement of NYHA from basement
Time frame: 7 days after operation, 30 days after operation, 3 months after operation
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