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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Transcatheter mitral valve repair system
Department of Cardiology, West China Hospital, Sichuan University
Sichuan, China
RECRUITINGEfficacy 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).
Time frame: 12 months
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).
Time frame: 30 days, 180 days, 2 to 5 years
Rate of Cardiovascular related mortality
Cardiovascular related mortality after Transcatheter Mitral Valve Repairment
Time frame: 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.)
Time frame: 30 days, 180 days, 1 year, 2 to 5 years
Quality of life Improvement
The 12-Item Short-Form Health Survey(SF-12)
Time frame: 30 days, 180 days, 1 year, 2 to 5 years
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