Mitral RegurgitationEXPLORE-MRaceNCT07517588
EFS of Posterior Leaflet Replacement to Reduce Mitral Regurgitation (United States)
A study testing MR-ace Implant and Delivery System in people with Mitral Regurgitation, run by Polares Medical SA at 3 sites in United States.
Trial summary
The goal of this early feasibility clinical trial is to learn if the device MR-ace Implant and Delivery System works in patients with moderate or severe mitral valve regurgitation. It will also learn about the safety of the device MR-ace Implant and Delivery System. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- MR-ace Implant and Delivery System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Sep 2026to 31 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
- Patient has symptomatic moderate-to-severe to severe functional mitral regurgitation despite stable doses of maximally tolerated guideline directed medical therapy (GDMT) per the Local Heart Team.
- Note: In the 30 days prior to performing screening assessments, no new GDMT medications should be introduced and current doses should be stable (i.e. no decrease of > 50% or increase of > 100%) excluding diuretics. Any changes beyond this range would not be considered stable GDMT.
- Functional MR graded 3+ or higher (using a scale of 0 to 4+) by transthoracic echocardiography (TTE) within 60 days prior to study procedure as evaluated by the sponsor's Echo Core Lab.
- New York Heart Association (NYHA) Functional Class II, III or ambulatory IV heart failure
- Patient must present with an STS Score less than 10% and deemed by the Local Heart Team to be at high risk but operable for mitral valve surgery.
- The Local Heart Team deems the patient unsuitable for commercially approved transcatheter mitral valve therapies
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- 21 years of age or older
- Native mitral valve geometry and size is compatible with the Polares MRace system
- Anatomy is suitable for transfemoral transseptal access with the Polares MRace system
- Patient is willing to participate in study and provides signed IRB/EC-approved informed consent
- Treating physician and patient agree that patient is able to return for all required post-procedure follow-up visits
- Patient is approved by an independent Patient Eligibility Committee
Who cannot join
- Echocardiographic parameters (any of the following, assessed by the Echo Core Lab)
- Left ventricular ejection fraction (LVEF) < 30%
- Pulmonary artery systolic pressure (PASP) > 70mmHg or > 2/3 SBP (Systolic Blood Pressure)
- Left Ventricle End Diastolic Volume (LV EDV) > 200 mL
- Left Ventricle End Systolic Volume (LV ESV) > 140 mL
- Left Ventricle End Diastolic Diameter (LV EDD) > 70 mm
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- Left Ventricle End Systolic Diameter (LV ESD) > 55 mm
- Severe Right Ventricle (RV) dysfunction as per assessment by Local Heart Team or Eligibility Committee .
- Severe tricuspid regurgitation.
- Severe aortic stenosis or insufficiency.
- Severe mitral annulus calcification.
- Diseased mitral anterior and/or posterior leaflet, such as flail, / prolapse, or/ heavy moderate to severe calcification.
- Barlow's disease.
- Presence of an implanted vena cava filter or any other device (e.g. ASD closure device) that may interfere with femoral vein access or delivery system access to the mitral valve.
- Contraindication for transesophageal echocardiography (TEE) or MDCT scan
- Active infection or endocarditis or infection requiring antibiotic therapy within 2 weeks of scheduled procedure.
- Previous mitral valve surgery or transcatheter mitral valve procedure.
- Prior orthotopic heart transplantation.
- Evidence of intra-cardiac, inferior vena cava (IVC) or femoral venous thrombus. History of deep vein thrombosis (DVT) or pulmonary embolism within 6 months of the index procedure.
- Untreated Class I indication for pacing (CRT). Implant or revision of any pacing device < 30 days prior to intervention
- Any untreated clinically significant coronary artery disease requiring revascularization. Coronary, carotid, or endovascular artery disease treated percutaneously < 30 days prior to study procedure. Cardiac surgery < 90 days prior to study procedure.
- Myocardial infarction requiring intervention < 30 days prior to study procedure
- Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis), hypertrophic or restrictive cardiomyopathies, and constrictive pericarditis)
- Active peptic ulcer or upper gastrointestinal bleeding < 90 days prior to study procedure.
- Stroke < 180 days prior to study procedure.
- Severe COPD requiring oral steroid therapy or oxygen therapy.
- Severe renal insufficiency (creatinine > 3.0 mg/dL) or patient requiring dialysis
- Cardiogenic shock at time of enrolment. Hemodynamic instability requiring inotropic support or mechanical heart assistance.
- Concurrent medical condition with a life expectancy of less than 2 years
- Pregnancy or breastfeeding at time of enrolment with a positive pregnancy test within 14 days of study procedure.
- History of bleeding diathesis or coagulopathy or leukopenia (WBC < 3,000 mcL) or acute anemia (Hb < 9 g/dL) or thrombocytopenia (platelets < 50,000 cells mcL)
- Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, nitinol, tantalum or allergy to contrast agents that cannot be pre-medicated.
- Note. Patient must be able to tolerate at least one antiplatelet medication AND one anticoagulant medication.
- Severe dementia or lack of capacity due to conditions that result in either inability to provide informed consent for the trial/procedure, prevent independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up assessments.
- Patient is in need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.
- Company employees or their immediate family members.
- Patient is considered to be part of a vulnerable population, is under guardianship, or subject to any other medical, social or psychological conditions that preclude appropriate consent and follow-up.
- Patient is participating in another clinical study for which follow-up is currently ongoing.
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
Emory Midtown
Atlanta, Georgia, 30308
Elizabeth Charles, 404-686-1249, elizabeth.z.charles@emory.edu
Adam Greenbaum, MD
- Not yet recruiting
The Lindner Research Center at The Christ Hospital
Cincinnati, Ohio, 45219
Katy Fischesser, 513-585-1777, Katy.Fischesser@thechristhospital.com
Santiago Garcia, MD
- Not yet recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Tammy Guzman, 718-920-4595, Tamrodrigu@montefiore.org
Mohamad Latib, MD
About this study
Official title: Early Feasibility Experience of Posterior Leaflet Replacement to Reduce Mitral Regurgitation Using the MRace Implant (United States)
The goal of this early feasibility clinical trial is to learn if the device MR-ace Implant and Delivery System works in patients with moderate or severe mitral valve regurgitation. It will also learn about the safety of the device MR-ace Implant and Delivery System. The main questions it aims to answer are:
Does implanting the MR-ace device reduce the symptoms of mitral regurgitation? Does the device reduce the the leak through your mitral valve?
Participants will:
Be implanted with the device Visit the clinic for checkups and tests at 30 days, 6 months, 12 months, and 2, 3, 4 and 5 years following your procedure Complete a quality of life survey
- Conditions
- Mitral Regurgitation
- Being tested
- MR-ace Implant and Delivery System
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-ace Implant and Delivery SystemDevice
This study device uses a transcatheter procedure through your leg veins to place the MRace implant and cover the posterior leaflet of your own mitral valve.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | treatment with the study device Receives: Device: MR-ace Implant and Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
All-cause mortality
Measured: 30 days post procedure
Primary Performance Endpoint
Reduction in mitral regurgitation (Grade 2+ or less) as evaluated by 2D transthoracic echocardiography.
Measured: 30 days post procedure
Secondary outcomes (2)
Secondary Safety Endpoint
Rate of major safety events using MVACR2 classification
Measured: 30 days, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years post procedure
Secondary Performance Endpoint
MVARC2 success criteria
Measured: 30 days, 6 months, 12 months, 2 yrs, 3 years, 4 years, and 5 years post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Polares Medical SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517588
- Sponsor's protocol ID
- 202501
- Acronym
- EXPLORE-MRace
- Status last verified
- Aug 2026
- First submitted
- 30 Mar 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: There is potential to present findings at conference.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Experience of Posterior Leaflet Replacement to Reduce Mitral Regurgitation Using the MRace Implant (United States)
- ClinicalTrials.gov ID
- NCT07517588
- Acronym / sponsor ID
- EXPLORE-MRace / 202501
- Conditions
- Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Polares Medical SAIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 8 Apr 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.
The goal of this early feasibility clinical trial is to learn if the device MR-ace Implant and Delivery System works in patients with moderate or severe mitral valve regurgitation. It will also learn about the safety of the device MR-ace Implant and Delivery System. The main questions it aims to answer are:
Does implanting the MR-ace device reduce the symptoms of mitral regurgitation? Does the device reduce the the leak through your mitral valve?
Participants will:
Be implanted with the device Visit the clinic for checkups and tests at 30 days, 6 months, 12 months, and 2, 3, 4 and 5 years following your procedure Complete a quality of life survey
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: MR-ace Implant and Delivery Systemtreatment with the study device |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient has symptomatic moderate-to-severe to severe functional mitral regurgitation despite stable doses of maximally tolerated guideline directed medical therapy (GDMT) per the Local Heart Team.
- Note: In the 30 days prior to performing screening assessments, no new GDMT medications should be introduced and current doses should be stable (i.e. no decrease of > 50% or increase of > 100%) excluding diuretics. Any changes beyond this range would not be considered stable GDMT.
- Functional MR graded 3+ or higher (using a scale of 0 to 4+) by transthoracic echocardiography (TTE) within 60 days prior to study procedure as evaluated by the sponsor's Echo Core Lab.
- New York Heart Association (NYHA) Functional Class II, III or ambulatory IV heart failure
- Patient must present with an STS Score less than 10% and deemed by the Local Heart Team to be at high risk but operable for mitral valve surgery.
Key exclusion criteria (38 listed)
- Echocardiographic parameters (any of the following, assessed by the Echo Core Lab)
- Severe Right Ventricle (RV) dysfunction as per assessment by Local Heart Team or Eligibility Committee .
- Severe tricuspid regurgitation.
- Severe aortic stenosis or insufficiency.
- Severe mitral annulus calcification.
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 |
|---|---|---|
| MR-ace Implant and Delivery SystemThis study device uses a transcatheter procedure through your leg veins to place the MRace implant and cover the posterior leaflet of your own mitral valve. | Device | Treatment |
Primary outcome
Primary Safety Endpoint
Time frame: 30 days post procedure
All-cause mortality
Primary Performance Endpoint
Time frame: 30 days post procedure
Reduction in mitral regurgitation (Grade 2+ or less) as evaluated by 2D transthoracic echocardiography.
2 secondary outcomes
Secondary Safety Endpoint
Time frame: 30 days, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years post procedure
Secondary Performance Endpoint
Time frame: 30 days, 6 months, 12 months, 2 yrs, 3 years, 4 years, and 5 years 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 1 Sep 2026.
- Individual participant dataSharing planned: Undecided. There is potential to present findings at conference.
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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.
The Lindner Research Center at The Christ Hospital
Cincinnati, United States
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR-ace Implant and Delivery System in people with Mitral Regurgitation, run by Polares Medical SA 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 12 inclusion and 38 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 1 Sep 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint (time frame: 30 days post procedure). The study lists 2 primary outcomes in all. 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 1 Sep 2026.