ENHANCE EFS: Early Feasibility Study (EFS) of the Nyra Cardiac Leaflet Enhancer (CARLEN) System
Nyra Medical, Inc.
Summary
Safety and performance evaluation of the CARLEN System in patients with functional mitral valve regurgitation.
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.
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Age \> 21 years at time of enrollment * Patient has provided informed consent, is willing and capable of participating in all testing, and agrees to return for all required post-procedure follow-up visits * Moderate-to-severe or severe (MR ≥ 3+) functional (secondary) mitral valve regurgitation * Symptomatic with mitral regurgitation (NYHA Class II, III, or ambulatory IV) despite maximally-tolerated guideline-directed medical therapy (GDMT) as determined by the local multidisciplinary Heart Team * Patient is suitable for transcatheter mitral valve repair as determine…
Interventions
- DeviceCARLEN System
CARLEN System
Locations (3)
- University of California, DavisSacramento, California
- University of MichiganAnn Arbor, Michigan
- The Christ HospitalCincinnati, Ohio