Mitral Regurgitation FunctionalENHANCE EFSNCT07503236
Early Feasibility Study (EFS) of the Nyra Cardiac Leaflet Enhancer (CARLEN) System
A study testing CARLEN System in people with Mitral Regurgitation Functional, run by Nyra Medical, Inc. at 3 sites in United States.
Trial summary
Safety and performance evaluation of the CARLEN System in patients with functional mitral valve regurgitation. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Mitral Regurgitation Functional
- What is being tested?
- CARLEN System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Jul 2026to Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
- Recruiting
The Christ Hospital
Cincinnati, Ohio, 45219
- Recruiting
University of California, Davis
Sacramento, California, 95616
About this study
Official title: 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.
Read the 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.
- Conditions
- Mitral Regurgitation Functional
- Being tested
- CARLEN System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARLEN SystemDevice
CARLEN System
| Study group | Role | What they receive |
|---|---|---|
| CARLEN System | Experimental | CARLEN System Receives: Device: CARLEN System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint
Freedom from device- or procedure-related serious adverse events through 30-days post-procedure
Measured: 30-days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start2 Jul 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Regurgitation FunctionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nyra Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503236
- Sponsor's protocol ID
- CIP-002
- Acronym
- ENHANCE EFS
- Status last verified
- Jul 2026
- First submitted
- 25 Mar 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENHANCE EFS: Early Feasibility Study (EFS) of the Nyra Cardiac Leaflet Enhancer (CARLEN) System
- ClinicalTrials.gov ID
- NCT07503236
- Acronym / sponsor ID
- ENHANCE EFS / CIP-002
- Conditions
- Mitral Regurgitation Functional
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nyra Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Jul 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety and performance evaluation of the CARLEN System in patients with functional mitral valve regurgitation.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CARLEN System | Experimental | Device: CARLEN SystemCARLEN System |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CARLEN SystemCARLEN System | Device | CARLEN System |
Primary outcome
Primary Endpoint
Time frame: 30-days post-procedure
Freedom from device- or procedure-related serious adverse events through 30-days post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CARLEN System in people with Mitral Regurgitation Functional, run by Nyra Medical, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Mischke, VP of Regulatory and Clinical (888 397 8046, jmischke@nyra-medical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint (time frame: 30-days post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.