Mi-thos® Transcatheter Mitral Valve Replacement(First-in-Man Study)
NCT05784337 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11
Last updated 2023-03-24
Summary
To evaluate the effectiveness and safety of the Mi-thos® Transcatheter Mitral Valve Replacement System in the treatment of patients with moderate or greater mitral regurgitation who are at high risk for conventional surgery, or who are not candidates for conventional surgery.
Conditions
- Mitral Valve Regurgitation
Interventions
- DEVICE
-
Mi-thos® Transcatheter Mitral Valve Replacement System
Transcatheter Mitral Valve Replacement
Sponsors & Collaborators
-
Shanghai NewMed Medical Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-04-21
- Primary Completion
- 2023-01-10
- Completion
- 2023-01-10
Countries
- China
Study Locations
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