Mitral Valve DiseaseEXPLORE_MRaceNCT07796659
EXPLORE MRace (GE): Early Feasibility Experience of Posterior Leaflet Restoration to Reduce Mitral Regurgitation Using the MRace Implant
A study testing Transcatheter mitral valve repair (MRace Implant and Delivery System) in people with Mitral Valve Disease, run by Polares Medical SA at 4 sites in Georgia.
Trial summary
An early feasibility study to evaluate the safety and feasibility of the MRace Implant and Delivery System to treat severe mitral regurgitation and to gather preliminary data on its performance thereby providing guidance for future clinical development. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Disease
- What is being tested?
- Transcatheter mitral valve repair (MRace Implant and Delivery System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesGeorgia
- Study dates
- 23 May 2022to 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
- 18 years of age or older
- Greater than moderate mitral regurgitation (Grade 3+ or higher) as confirmed by transesophageal echocardiography (TEE) within 90 days prior to study procedure
- Patient must present with an STS Score less than 10%
- High surgical risk for conventional mitral repair or replacement due to morphological criteria (e.g. leaflet or annulus calcifications), but operable, as assessed by the local heart team comprised of a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in treating mitral valve disease and heart failure
- New York Heart Association (NYHA) Functional Class III or IV
- Patient willing to participate in study and provide 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
Who cannot join
- Severe tricuspid regurgitation
- Severe aortic stenosis or insufficiency
- Severe mitral annulus calcification
- Diseased mitral anterior leaflet such as flail / prolapse/ heavy calcification
- Implanted vena cava filter
- Femoral veins with severe angulation and calcification
Show all 31Show fewer
- Contraindication for transesophageal echocardiography (TEE) or MDCT scan
- Active infection or endocarditis
- Previous mitral valve surgery
- Prior orthotopic heart transplantation
- Pulmonary artery systolic hypertension > 70mmHg
- Evidence of intra-cardiac, inferior vena cava (IVC) or femoral venous thrombus
- Left ventricular ejection fraction (LVEF) < 20%
- Implant or revision of any pacing device < 30 days prior to intervention
- Symptomatic coronary artery disease treated < 30 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 renal insufficiency (creatinine > 3.0 mg/dL) or Subject requiring dialysis
- Cardiogenic shock at time of enrollment
- 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 enrollment
- 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
- Emergency situations
- 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
- Company employees or their immediate family members
- Subject is under guardianship
- Subject is participating in another clinical study for which follow-up is currently ongoing.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Georgia4 sites, 4 recruiting
- Recruiting
Israeli-Georgian Medical Research Clinic Healthycore
Tbilisi, 0112
Gvantsa Dughashvili, MD, +995 599 509 003, dughashviligvantsaa@gmail.com
Irakli Gogorishvili, MD
- Recruiting
LLC "Emergency Cardilogy Center by Acad. G. Chapidze"
Tbilisi, 0159
Tinatin Kavtaradze, MD, +995 599 147 799, tinatinkavtaradze11@gmail.com
Alexander Aladashvili, MD
- Recruiting
Ltd Tbilisi Heart and Vascular Clinic
Tbilisi, 0159
Teona Zirakashvili, MD, + 995 555 291 018, zirakashvilit@gmail.com
Tamaz Shaburishvili, MD
- Recruiting
Ltd Tbilisi Heart Centre
Tbilisi, 0186
Ketevan Gabunia, MD, +995 599 577 977, kgabunia@tbhc.ge
Archil Chukhrukidze, MD
About this study
Official title: Early Feasibility Experience of Posterior Leaflet Restoration to Reduce Mitral Regurgitation Using the MRace Implant Brazil (EXPLORE MRace - GE)
An early feasibility study to evaluate the safety and feasibility of the MRace Implant and Delivery System to treat severe mitral regurgitation and to gather preliminary 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 100 patients at four (4) centers in the Republic of Georgia.
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 Implant and Delivery 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 Implant and Delivery System has been designed to overcome and mitigate some of these shortfalls
- Conditions
- Mitral Valve Disease
- Being tested
- Transcatheter mitral valve repair (MRace Implant and Delivery System)
- Keywords
- MR, FMR, Secondary MR, MVR, Mitral valve regurgitation
- 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.
Transcatheter mitral valve repair (MRace Implant and Delivery System)Device
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 Implant and Delivery System to treat severe mitral regurgitation All enrolled patients will receive the study device Receives: Device: Transcatheter mitral valve repair (MRace Implant and Delivery System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary safety outcome
Incidence of all-cause mortality following treatment with the MRace Implant and Delivery System
Measured: 30-days follow-up
Primary Performance Endpoint
Incidence of change from severe mitral regurgitation at baseline (Grade 3+ or more) to moderate or less mitral regurgitation (Grade 2+ or less) following treatment with the MRace Implant and Delivery System as evaluated by TTE
Measured: 30-days follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start23 May 2022
- 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 DiseaseStudies 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
- 100 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
- NCT07796659
- Sponsor's protocol ID
- 202202
- Acronym
- EXPLORE_MRace
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 Restoration to Reduce Mitral Regurgitation Using the MRace Implant Brazil (EXPLORE MRace - GE)
- ClinicalTrials.gov ID
- NCT07796659
- Acronym / sponsor ID
- EXPLORE_MRace / 202202
- Conditions
- Mitral Valve Disease
- Keywords
- MR, FMR, Secondary MR, MVR, Mitral valve regurgitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Polares Medical SAIndustry (pharma, biotech, devices)
- Study start
- 23 May 2022 (actual)
- Primary completion
- Dec 2032 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 1 Sep 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.
An early feasibility study to evaluate the safety and feasibility of the MRace Implant and Delivery System to treat severe mitral regurgitation and to gather preliminary 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 100 patients at four (4) centers in the Republic of Georgia.
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 Implant and Delivery 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 Implant and Delivery 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 repair (MRace Implant and Delivery System)Single-arm study of MRace Implant and Delivery 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 (7 listed)
- 18 years of age or older
- Greater than moderate mitral regurgitation (Grade 3+ or higher) as confirmed by transesophageal echocardiography (TEE) within 90 days prior to study procedure
- Patient must present with an STS Score less than 10%
- High surgical risk for conventional mitral repair or replacement due to morphological criteria (e.g. leaflet or annulus calcifications), but operable, as assessed by the local heart team comprised of a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in treating mitral valve disease and heart failure
- New York Heart Association (NYHA) Functional Class III or IV
Key exclusion criteria (31 listed)
- Severe tricuspid regurgitation
- Severe aortic stenosis or insufficiency
- Severe mitral annulus calcification
- Diseased mitral anterior leaflet such as flail / prolapse/ heavy calcification
- Implanted vena cava filter
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 repair (MRace Implant and Delivery System)The 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 outcome
Time frame: 30-days follow-up
Incidence of all-cause mortality following treatment with the MRace Implant and Delivery System
Primary Performance Endpoint
Time frame: 30-days follow-up
Incidence of change from severe mitral regurgitation at baseline (Grade 3+ or more) to moderate or less mitral regurgitation (Grade 2+ or less) following treatment with the MRace Implant and Delivery System as evaluated by TTE
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.
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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.
Israeli-Georgian Medical Research Clinic Healthycore
Tbilisi, Georgia
LLC "Emergency Cardilogy Center by Acad. G. Chapidze"
Tbilisi, Georgia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter mitral valve repair (MRace Implant and Delivery System) in people with Mitral Valve Disease, run by Polares Medical SA at 4 sites in Georgia.
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 7 inclusion and 31 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 4 sites in Georgia. 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 outcome (time frame: 30-days follow-up). 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.