Clinical Investigation for the Foldax Tria Mitral Valve- India
NCT06191718 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2024-01-05
Summary
The purpose of this study is to conduct a clinical investigation of the Foldax Tria Mitral Valve to collect evidence on the device's safety and performance.
Conditions
- Mitral Valve Disease
- Mitral Regurgitation
- Mitral Stenosis
- Mitral Valve Insufficiency
Interventions
- DEVICE
-
Mitral Valve Replacement
Foldax Mitral Valve Replacement
Sponsors & Collaborators
-
Foldax, Inc
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-03-01
- Primary Completion
- 2024-12-01
- Completion
- 2024-12-01
Countries
- India
Study Locations
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