Recruiting

CARLEN System

Sponsor:

Nyra Medical, Inc.

Code:

NCT07503236

Conditions

Mitral Regurgitation Functional

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

CARLEN System

Study Details

Brief summary:

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

Conditions

Mitral Regurgitation Functional

Study ID

NCT07503236

Start date

Jul 2, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2032

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CARLEN System

CARLEN System

Interventions

CARLEN System

CARLEN System

Primary outcome measure

  • Primary Endpoint [ Time Frame: 30-days post-procedure ]

Central Contacts and Locations

Central contacts

Jennifer Mischke, VP of Regulatory and Clinical

888 397 8046jmischke@nyra-medical.com

Locations

University of California, Davis

Recruiting

Sacramento, California, United States, 95616

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

The Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

More Information

Sponsor

Nyra Medical, Inc.

Last update posted

Jul 28, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nyra Medical, Inc. on 2026-07-28.