Nyra CARLEN System for Functional Mitral Regurgitation
Official title: ENHANCE EFS: Early Feasibility Study (EFS) of the Nyra Cardiac Leaflet Enhancer (CARLEN) System
Run by Nyra Medical, Inc. · NCT07503236 · Data updated 2026-11-12
A first-in-human-feasibility test to see if the CARLEN system is safe and can perform well in people with symptomatic functional mitral valve regurgitation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Nyra Medical, Inc. Industry-sponsored |
| Locations | 3 sites (Sacramento, California and 2 other locations) |
| Status | Recruiting |
| Started | July 2, 2026 |
| Main results expected | December 2027 |
| Study ends | December 2032 |
| Registry record updated | July 28, 2026 |
| Trial ID | NCT07503236 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 21 with symptomatic functional MR (MR ≥ 3+) who are suitable for transcatheter repair and have failing GDMT.
✕Probably not a fit
Patients with limited life expectancy, pregnancy-related exclusions, or anatomy not suitable for transcatheter repair may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This early feasibility study tests the CARLEN System as a transcatheter approach for patients with moderate-to-severe or severe functional MR who remain symptomatic despite guideline-directed medical therapy. The study focuses on safety and device performance in a real-world setting across three academic centers. Eligible participants are adults with MR ≥3+ and NYHA class II–IV, who are suitable for transcatheter repair. Key exclusion criteria include limited life expectancy and certain pregnancy-related considerations. The trial is sponsored by Nyra Medical, with sites at UC Davis, University of Michigan, and The Christ Hospital.
Why it matters
Potential benefit: If successful, patients could experience improved valve function and symptom relief from MR.
How similar studies have gone: Early feasibility work on similar transcatheter approaches has shown promise but this specific CARLEN system is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 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 it's running
-
University of California, Davis
Sacramento, California, United States Recruiting -
University of Michigan
Ann Arbor, Michigan, United States Recruiting -
The Christ Hospital
Cincinnati, Ohio, United States Recruiting
Study contacts
- Study coordinator: Jennifer Mischke, VP of Regulatory and Clinical
- Email: jmischke@nyra-medical.com
- Phone: 888 397 8046
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Achieving Optimal Medical Therapy Through Transcatheter Mitral Repair in HFrEF
This trial tests whether early transcatheter edge-to-edge repair (M-TEER) helps patients with HFrEF and secondary MR reach guideline-directed medical therapy faster and more completely, and whether that improves quality of life and outcomes.
-
Mitral Valve Edge-to-Edge Repair for exercise-induced severe mitral regurgitation in heart failure patients
This trial tests whether adding mitral valve TEER to standard heart failure treatment helps people with exercise-triggered severe mitral regurgitation feel better and stay healthier.
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Using the Dragonfly system to treat severe mitral regurgitation
This study is testing a new device called the Dragonfly to see if it can help people with severe mitral regurgitation who still have symptoms despite taking their medications.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.