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Mi-thos® Transcatheter Mitral Valve Replacement Study
Sponsor: Shanghai NewMed Medical Co., Ltd.
Summary
To evaluate the safety and performance of the Mi-thos® Mitral Heart Valve with the Mi-thos® Transcatheter Delivery System.
Official title: Evaluation of the Efficacy and Safety of the Mi-thos® Transcatheter Mitral Valve Replacement System in Patients with Severe Mitral Valve Disease At High Surgical Risk.
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
122
Start Date
2021-03-25
Completion Date
2027-01
Last Updated
2025-02-13
Healthy Volunteers
No
Conditions
Interventions
Mi-thos® valve and transapical delivery system
Transcatheter mitral valve replacement system
Locations (3)
Fuwai hospital
Beijing, Beijing Municipality, China
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Xijing hospital
Xi’an, Shanxi, China