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

April 6, 2026 updated by: Nyra Medical, Inc.

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this early feasibility study (EFS) is to evaluate the safety and performance of the CARLEN System in patients with symptomatic, moderate-to-severe or severe (MR ≥ 3+), functional (or secondary) mitral regurgitation.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CARLEN System
Device: CARLEN System
CARLEN System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Endpoint
Time Frame: 30-days post-procedure
Freedom from device- or procedure-related serious adverse events through 30-days post-procedure
30-days post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nyra Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2032

Study Registration Dates

First Submitted

March 25, 2026

First Submitted That Met QC Criteria

March 25, 2026

First Posted (Actual)

March 31, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • CIP-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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