MATTERS II - Mistral Percutaneous Tricuspid Valve Repair FIM Study
NCT04073979 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2023-10-19
Summary
The Mistral is an investigational device intended for percutaneous trans-catheter repair in high risk for surgery individuals suffering from functional Tricuspid Regurgitation (TR).
The device system is to be used only in accordance with the approved Investigational Plan on subjects who have signed an informed consent form. Device use is limited to the approved study investigators.
Conditions
- Tricuspid Valve Regurgitation
Interventions
- DEVICE
-
Mistral implantation
Mistral implant is implanted in the Tricuspid valve
Sponsors & Collaborators
-
Mitralix
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-04-02
- Primary Completion
- 2021-01-31
- Completion
- 2022-12-31
Countries
- Germany
Study Locations
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