To evaluate the safety and performance of the Mi-thos® Mitral Heart Valve with the Mi-thos® Transcatheter Delivery System.
The Mi-thos® study is an multicenter, single-arm, prospective, safety and performance clinical study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
122
Transcatheter mitral valve replacement system
Fuwai hospital
Beijing, Beijing Municipality, China
RECRUITINGZhongshan Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGXijing hospital
Xi’an, Shanxi, China
RECRUITINGFreedom from all-cause mortality
All-cause mortality after TMVR
Time frame: 1 year
Freedom from all-cause mortality
All-cause mortality after TMVR
Time frame: 30 days, 6months, 2-5 years
Severe adverse event rate
Severe adverse events rate after TMVR
Time frame: 30 days, 6months, 1 year, 2-5 years
NYHA Heart Function Rating
NYHA Heart Function Rating after TMVR
Time frame: 30 days, 6months, 1 year, 2-5 years
Kansas City Cardiomyopathy score
Kansas City Cardiomyopathy score after TMVR
Time frame: 30 days, 6months, 1 year, 2-5 years
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