Early Feasibility Study (EFS) of the Nyra Cardiac Leaflet Enhancer (CARLEN) System
ConditionMitral Regurgitation Functional
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorNyra Medical, Inc.
About this trial
Safety and performance evaluation of the CARLEN System in patients with functional mitral valve regurgitation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
CARLEN System
DeviceCARLEN System
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: CARLEN SystemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary Endpoint
Freedom from device- or procedure-related serious adverse events through 30-days post-procedure
Time frame
30-days post-procedureSponsors and contacts
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Source ClinicalTrials.gov