Clinical Trial

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

Study acronym: ENHANCE EFS
Recruiting
View on ClinicalTrials.gov →
Summary
Safety and performance evaluation of the CARLEN System in patients with functional mitral valve regurgitation.
Protocol Amendment History 8 changes
critical Recruitment opened 2026-07-29
notable Trial sites expanded: 0 -> 3 locations 2026-07-29
critical Trial status changed: Withheld → Not Yet Recruiting 2026-04-14
critical Phase changed: not specified -> not applicable 2026-04-14
critical Primary endpoint(s) modified 2026-04-14
notable Enrollment changed: None -> 30 2026-04-14
notable Sponsor changed: [Redacted] -> Nyra Medical, Inc. 2026-04-14
minor Trial arms changed: 0 -> 1 2026-04-14
Trial Details
NCT Number NCT07503236
Lead Sponsor Nyra Medical, Inc.
Conditions Mitral Regurgitation Functional
Enrollment 30 participants
Start Date 2026-07-02
Primary Completion 2027-12 (estimated)
Study Completion 2032-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-28