Retrospective Clinical Data Collection on Carbomedics OptiForm Mitral Heart Valve
NCT05898230 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400
Last updated 2024-03-07
Summary
The objective of this study is to evaluate the medium- to long-term safety of the Carbomedics OptiForm Mitral Heart Valve after the implantation for mitral valve disease in the Chinese population.
The study is designed as a post-market, retrospective, single arm and multicentric data collection
Conditions
- Mitral Valve Disease
Interventions
- DEVICE
-
Mitral Valve Replacement
Mitral Valve Replacement with Carbomedics OptiForm Mitral Heart Valve
Sponsors & Collaborators
-
Corcym S.r.l
lead INDUSTRY
Principal Investigators
-
Sara Gaggianesi · Corcym S.r.l
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-23
- Primary Completion
- 2024-12-31
- Completion
- 2024-12-31
- FDA Device
- Yes
Countries
- China
Study Locations
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