Trials / Not Yet Recruiting
Not Yet RecruitingNCT07503236
Early Feasibility Study (EFS) of the Nyra Cardiac Leaflet Enhancer (CARLEN) System
ENHANCE EFS: Early Feasibility Study (EFS) of the Nyra Cardiac Leaflet Enhancer (CARLEN) System
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Nyra Medical, Inc. · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
Safety and performance evaluation of the CARLEN System in patients with functional mitral valve regurgitation.
Detailed description
The purpose of this early feasibility study (EFS) is to evaluate the safety and performance of the CARLEN System in patients with symptomatic, moderate-to-severe or severe (MR ≥ 3+), functional (or secondary) mitral regurgitation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CARLEN System | CARLEN System |
Timeline
- Start date
- 2026-06-01
- Primary completion
- 2027-12-01
- Completion
- 2032-12-01
- First posted
- 2026-03-31
- Last updated
- 2026-04-13
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07503236. Inclusion in this directory is not an endorsement.