Mitral Valve (MV) RegurgitationACCESS-MR (AU)NCT07757698
A Prospective, Multicenter, Single-Arm Study to Support the Clinical Evidence Base for MRace as a Treatment Option for FMR Patients With Complex M-TEER Anatomies (AU)
A study testing Transcatheter mitral valve repair in people with Mitral Valve (MV) Regurgitation, run by Polares Medical SA.
Trial summary
A pilot study to evaluate the safety and performance of the MRace System to treat severe mitral regurgitation and to gather data on its performance thereby providing guidance for future clinical development. The study is a single-arm registry with the last follow-up visit at 5 years post-intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve (MV) Regurgitation
- What is being tested?
- Transcatheter mitral valve repair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Nov 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 18 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 optimized 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 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's anatomy to be unsuitable for M-TEER.
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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 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 (PEC) which will confirm the presence of at least of the following one complex anatomical feature:
- Atrial Functional MR with coaptation depth <5-mm
- PLM length < 10 mml
- Gap-Width > 10-18 mm
- Coaptation reserve < 3 mm where the jet is present
- LAI (Leaflet to Annulus-Index) < 1.2
- MVA < 2.5-4.0 cm2
- Leaflet calcium in the M-TEER grasping zone
- Coaptation depth > 10 mm
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) > 200mL for males; >130mL for females
- Left Ventricle End Systolic Volume (LV ESV) > 70 mL
- Left Ventricle End Diastolic Diameter (LV EDD) > 70 mm
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- Left Ventricle End Systolic Diameter (LV ESD) > 55 mm
- Anatomical features as per assessment by Local Heart Team and confirmed by the Patient Eligibility Committee
- IC > 4 5mm
- PML > 14 mm
- MR width > 18 mm
- Severe MAC
- PM height < 20 mm
- AML or PML prolapse
- Mean gradient > 5 mmHg
- Barlow's disease
- Severe Right Ventricle (RV) dysfunction as per assessment by Local Heart Team or Patient 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.
- 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 72 hours before any study-related radiation exposure.
- 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.
About this study
Official title: A Prospective, Multicenter, Single-Arm Study to Support the Clinical Evidence Base for MRace as a Treatment Option for FMR Patients With Complex M-TEER Anatomies - AUSTRALIA
A pilot study to evaluate the safety and performance of the MRace System to treat severe mitral regurgitation and to gather data on its performance thereby providing guidance for future clinical development. The study is a single-arm registry with the last follow-up visit at 5 years post-intervention. The study will enroll up to 15 patients at 1 center in Australia
Read the detailed description
Percutaneous approaches to treat MR promise to provide a sufficient reduction in MR without the risks typically associated with open heart surgery. Furthermore there is an unmet clinical need for patients with severe MR who are refused or denied surgery due to high risk. Percutaneous therapy provides a novel alternative treatment option for these patients with the aim of reducing morbidity and mortality over and above current medical therapy. The Polares Medical MRace System is a catheter-based technology designed to permanently implant a prosthesis using a transvenous / transseptal approach to augment the posterior mitral valve leaflet and improve coaptation with the anterior leaflet. Approved edge-to-edge repair has already been shown to be a viable alternative for high risk MR patients. However treatment with these devices is limited to specific anatomies and often requires multiple devices which increases clinical risk, adds to procedural time, and can result in residual MR. The MRace System has been designed to overcome and mitigate some of these shortfalls.
- Conditions
- Mitral Valve (MV) Regurgitation
- Being tested
- Transcatheter mitral valve repair
- Keywords
- Mitral Valve Regurgitation, MV Regurgitation, MVR, Secondary Mitral Regurgitation, Secondary MR, Functional Mitral Regurgitation, Functional MR, FMR, MR, TMVR, Transcather Mitral Valve Repair, M-TEER
- Medical subject headings
- Gastroesophageal Reflux, Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter mitral valve repairDevice
The MRace Implant is placed mitral valve posterior annulus using its delivery system via femoral vein access and a transeptal puncture
| Study group | Role | What they receive |
|---|---|---|
| MRace Arm | Experimental | Single-arm study of MRace System to treat severe mitral regurgitation All enrolled patients will receive the study device Receives: Device: Transcatheter mitral valve repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
The primary safety endpoint is all-cause mortality at 30 days post-index procedure.
Measured: 30 days post-index procedure
Primary Performance Endpoint
Improvement from baseline to moderate or less mitral regurgitation (Grade 2+ or less) at 30 days as evaluated by 2D transthoracic echocardiography.
Measured: 30 days post-index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2032 (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 Valve (MV) 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
- Model description
- Single-arm registry
- 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
- NCT07757698
- Sponsor's protocol ID
- 202603
- Acronym
- ACCESS-MR (AU)
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-Arm Study to Support the Clinical Evidence Base for MRace as a Treatment Option for FMR Patients With Complex M-TEER Anatomies - AUSTRALIA
- ClinicalTrials.gov ID
- NCT07757698
- Acronym / sponsor ID
- ACCESS-MR (AU) / 202603
- Conditions
- Mitral Valve (MV) Regurgitation
- Keywords
- Mitral Valve Regurgitation, MV Regurgitation, MVR, Secondary Mitral Regurgitation, Secondary MR, Functional Mitral Regurgitation, Functional MR, FMR
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Polares Medical SAIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2032 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 11 Aug 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.
A pilot study to evaluate the safety and performance of the MRace System to treat severe mitral regurgitation and to gather data on its performance thereby providing guidance for future clinical development. The study is a single-arm registry with the last follow-up visit at 5 years post-intervention. The study will enroll up to 15 patients at 1 center in Australia
Detailed description
Percutaneous approaches to treat MR promise to provide a sufficient reduction in MR without the risks typically associated with open heart surgery. Furthermore there is an unmet clinical need for patients with severe MR who are refused or denied surgery due to high risk. Percutaneous therapy provides a novel alternative treatment option for these patients with the aim of reducing morbidity and mortality over and above current medical therapy. The Polares Medical MRace System is a catheter-based technology designed to permanently implant a prosthesis using a transvenous / transseptal approach to augment the posterior mitral valve leaflet and improve coaptation with the anterior leaflet. Approved edge-to-edge repair has already been shown to be a viable alternative for high risk MR patients. However treatment with these devices is limited to specific anatomies and often requires multiple devices which increases clinical risk, adds to procedural time, and can result in residual MR. The MRace System has been designed to overcome and mitigate some of these shortfalls.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm registry
| Arm | Type | Receives |
|---|---|---|
| MRace Arm | Experimental | Device: Transcatheter mitral valve repairSingle-arm study of MRace System to treat severe mitral regurgitation All enrolled patients will receive the study device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patient has symptomatic moderate-to-severe to severe functional mitral regurgitation despite stable doses of optimized guideline-directed medical therapy (GDMT) per the Local Heart Team.
- Functional MR graded 3+ or higher 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's anatomy to be unsuitable for M-TEER.
Key exclusion criteria (46 listed)
- Echocardiographic parameters (any of the following, assessed by the Echo Core Lab)
- Anatomical features as per assessment by Local Heart Team and confirmed by the Patient Eligibility Committee
- Severe Right Ventricle (RV) dysfunction as per assessment by Local Heart Team or Patient Eligibility Committee.
- Severe tricuspid regurgitation.
- Severe aortic stenosis or insufficiency.
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 |
|---|---|---|
| Transcatheter mitral valve repairThe MRace Implant is placed mitral valve posterior annulus using its delivery system via femoral vein access and a transeptal puncture | Device | MRace Arm |
Primary outcome
Primary Safety Endpoint
Time frame: 30 days post-index procedure
The primary safety endpoint is all-cause mortality at 30 days post-index procedure.
Primary Performance Endpoint
Time frame: 30 days post-index procedure
Improvement from baseline to moderate or less mitral regurgitation (Grade 2+ or less) at 30 days as evaluated by 2D transthoracic echocardiography.
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 11 Aug 2026.
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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 record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter mitral valve repair in people with Mitral Valve (MV) Regurgitation, run by Polares Medical SA.
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 20 inclusion and 46 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: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint (time frame: 30 days post-index 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 11 Aug 2026; AzTrials last refreshed its copy on 27 Oct 2026.