Early Feasibility Study (EFS) of the Nyra Cardiac Leaflet Enhancer (CARLEN) System

Part of paid clinical trials in Sacramento, California.

Sponsor
Nyra Medical, Inc.
Study ID
NCT07503236
Status
Recruiting
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Conditions

  • Mitral Regurgitation Functional

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CARLEN System — DEVICE
    CARLEN System

Study Details

Safety and performance evaluation of the CARLEN System in patients with functional mitral valve regurgitation.

Key Dates

First listed
Mar 31, 2026
Start date
Jul 2, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2032

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CARLEN System
    CARLEN System

Primary Outcome Measure

Primary Endpoint [ Time Frame: 30-days post-procedure ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of California, DavisSacramentoCalifornia95616-
University of MichiganAnn ArborMichigan48109-
The Christ HospitalCincinnatiOhio45219-

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By research site
University of California, Davis· Sacramento, CAUniversity of Michigan· Ann Arbor, MIThe Christ Hospital· Cincinnati, OH