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Early Feasibility Study of the Nyra Cardiac Leaflet Enhancer (CARLEN) System for Mitral Regurgitation

This study is testing the safety and performance of a new device called the CARLEN System. It's for people who have moderate-to-severe or severe functional mitral regurgitation (a condition where a heart valve doesn't close properly, causing blood to leak backward). You might be able to join if you are over 21, have symptoms from your mitral regurgitation, and are willing to participate in all study visits. The researchers will look at how safe and well the CARLEN System works for 30 days after the procedure. The study plans to enroll 30 participants, but its current recruitment status is unclear.

Study design
This is an early feasibility study, meaning it's one of the first times this device is being tested in people. It plans to include 30 participants.
What's involved
You would need to provide informed consent, be willing to participate in all testing, and agree to return for all required follow-up visits after the procedure.
Compensation
Not stated in the trial record.
Follow-up
Your safety and performance will be evaluated for 30 days after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07503236

Early Feasibility Study (EFS) of the Nyra Cardiac Leaflet Enhancer (CARLEN) System

Recruiting
NAAges 21+InterventionalTreatment
Nyra Medical, Inc.
~30 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:CARLEN System

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Endpoint
Measured over 30-days post-procedure

Conditions

Mitral Regurgitation Functional

Explore related trials

Mitral Valve Insufficiency

Where it's being run

3 sites across 3 states
California1
Michigan1
Ohio1

Who to contact

Jennifer Mischke, VP of Regulatory and Clinical
[email protected]
888 397 8046
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Primary Endpoint30-days post-procedure

    Freedom from device- or procedure-related serious adverse events through 30-days post-procedure