HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve
NCT04888247 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2024-10-03
Summary
Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system
Conditions
- Mitral Regurgitation
Interventions
- DEVICE
-
CLARITY
Trans-septal mitral valve replacement
Sponsors & Collaborators
-
HighLife SAS
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
- 2021-07-01
- Primary Completion
- 2025-12-01
- Completion
- 2031-02-01
Countries
- Australia
- Belgium
- France
- Germany
- Poland
- United Kingdom
Study Locations
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