Early Feasibility Study (EFS) of the Nyra Cardiac Leaflet Enhancer (CARLEN) System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CARLEN System.
- Who it may be relevant to
- Registry conditions: Mitral Regurgitation Functional. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
ENHANCE EFS: Early Feasibility Study (EFS) of the Nyra Cardiac Leaflet Enhancer (CARLEN) System
Overview
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.
Interventions
- Device CARLEN System
CARLEN System
Primary outcome measures
- Primary Endpoint [Time frame: 30-days post-procedure]
Eligibility criteria
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 determined by the local multidisciplinary Heart Team and confirmed by the Eligibility Committee
Exclusion criteria
- Estimated life expectancy of less than 12 months
- Women who are pregnant, lactating, or planning to become pregnant during the clinical study. Women of child-bearing potential must have negative pregnancy test result within 2 weeks prior to the procedure
- Left Ventricular Ejection Fraction (LVEF) < 20%
- Left ventricular end diastolic diameter (LVEDD) > 75 mm
- Acute hemodynamic decompensation
- Known hypersensitivity or contraindications to necessary and routine medications including contrast compounds or components used in the CARLEN System that cannot be successfully pre-medicated, including nitinol, an alloy of nickel and titanium
- Contraindicated for transesophageal echo (TEE)
- Presence of other anatomical characteristics and/or significant comorbidities that in the judgement of the Investigator or Eligibility Committee precludes the subject from participation
- Aortic valve disease requiring intervention or intervention
- Severe or greater tricuspid regurgitation
- Severe right ventricular dysfunction
- Severe pulmonary hypertension
- Presence of significant congenital heart disease
- Planned or scheduled cardiac surgery within next 12 months
- Endocarditis within last 90 days
- Evidence of intracardiac mass, vegetation, or inflammatory or infectious valve disease
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- University of California, Davis — Sacramento
- University of Michigan — Ann Arbor
- The Christ Hospital — Cincinnati
Identifiers
NCT: NCT07503236 · CIP-002