Mi-thos® Transcatheter Mitral Valve Replacement Study
NCT04195984 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122
Last updated 2025-02-13
Summary
To evaluate the safety and performance of the Mi-thos® Mitral Heart Valve with the Mi-thos® Transcatheter Delivery System.
Conditions
- Mitral Valve Regurgitation
Interventions
- DEVICE
-
Mi-thos® valve and transapical delivery system
Transcatheter mitral valve replacement system
Sponsors & Collaborators
-
Shanghai NewMed Medical Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Wang chunsheng, Chief · Shanghai Zhongshan Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-03-25
- Primary Completion
- 2026-05-31
- Completion
- 2027-01-31
Countries
- China
Study Locations
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