Early Feasibility Study (EFS) of the Nyra Cardiac Leaflet Enhancer (CARLEN) System
NCT07503236 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-04-13
Summary
Safety and performance evaluation of the CARLEN System in patients with functional mitral valve regurgitation.
Conditions
- Mitral Regurgitation Functional
Interventions
- DEVICE
-
CARLEN System
CARLEN System
Sponsors & Collaborators
-
Nyra Medical, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-30
- Primary Completion
- 2027-12-31
- Completion
- 2032-12-31
- FDA Device
- Yes
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