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

NCT07503236 | Recruiting DMC FDA Device

• 1 other identifier: CIP-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

Safety and performance evaluation of the CARLEN System in patients with functional mitral valve regurgitation.

Conditions

Mitral Regurgitation Functional

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint

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

  30-days post-procedure

Study Arms (1)

CARLEN System

EXPERIMENTAL

CARLEN System

Device: CARLEN System

Interventions

CARLEN System DEVICE

CARLEN System

CARLEN System

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nyra Medical, Inc.: lead

Study Sites (3)

University of California, Davis

Sacramento, California, 95616, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

The Christ Hospital

Cincinnati, Ohio, 45219, United States

RECRUITING

Central Study Contacts

Jennifer Mischke, VP of Regulatory and Clinical

CONTACT

888 397 8046; jmischke@nyra-medical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: March 31, 2026
• Study Start: July 2, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2032
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

US (3)