NCT07503236 · Nyra Medical, Inc.
Early Feasibility Study (EFS) of the Nyra Cardiac Leaflet Enhancer (CARLEN) System
(ENHANCE EFS)
What this study is about
Safety and performance evaluation of the CARLEN System in patients with functional mitral valve regurgitation.
View original scientific description
Safety and performance evaluation of the CARLEN System in patients with functional mitral valve regurgitation.
Interventions
DEVICE
CARLEN System
CARLEN System
Primary outcome measures
Primary Endpoint
Time frame: 30-days post-procedure
Freedom from device- or procedure-related serious adverse events through 30-days post-procedure
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 Key
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
Where
- Sacramento, California
- Ann Arbor, Michigan
- Cincinnati, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 28, 2026 · Source of record for eligibility and locations