MRace Posterior Leaflet Repair for Severe Mitral Regurgitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm registry enrolling up to 10 adults with severe MR at one Brazilian center to evaluate the safety and feasibility of a transcatheter MRace Implant and Delivery System. The study uses a transvenous/transseptal approach to augment the posterior leaflet and improve valve coaptation, aiming to reduce MR and guide future development. Follow-up continues for up to 5 years to gather preliminary performance data in a high-risk population. The trial focuses on patients with high surgical risk who are not suitable for conventional repair or replacement.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 18 years of age or older
2. Greater than moderate mitral regurgitation (Grade 3+ or higher) as confirmed by transesophageal echocardiography (TEE) within 90 days prior to study procedure
3. Patient must present with an STS Score less than 10%
4. 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
5. New York Heart Association (NYHA) Functional Class III or IV
6. Patient willing to participate in study and provide signed IRB/EC-approved informed consent
7. Treating physician and patient agree that patient is able to return for all required post-procedure follow-up visits

Exclusion Criteria:

1. Severe tricuspid regurgitation
2. Severe aortic stenosis or insufficiency
3. Severe mitral annulus calcification
4. Diseased mitral anterior leaflet such as flail / prolapse/ heavy calcification
5. Implanted vena cava filter
6. Femoral veins with severe angulation and calcification
7. Contraindication for transesophageal echocardiography (TEE) or MDCT scan
8. Active infection or endocarditis
9. Previous mitral valve surgery
10. Prior orthotopic heart transplantation
11. Pulmonary artery systolic hypertension \> 70mmHg
12. Evidence of intra-cardiac, inferior vena cava (IVC) or femoral venous thrombus
13. Left ventricular ejection fraction (LVEF) \< 30%
14. Implant or revision of any pacing device \< 30 days prior to intervention
15. Symptomatic coronary artery disease treated \< 30 days prior to study procedure
16. Myocardial infarction requiring intervention \< 30 days prior to study procedure
17. Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis), hypertrophic or restrictive cardiomyopathies, and constrictive pericarditis
18. Active peptic ulcer or upper gastrointestinal bleeding \< 90 days prior to study procedure
19. Stroke \< 180 days prior to study procedure
20. Severe renal insufficiency (creatinine \> 3.0 mg/dL) or patient requiring dialysis
21. Cardiogenic shock at time of enrolment
22. Hemodynamic instability requiring inotropic support or mechanical heart assistance
23. Concurrent medical condition with a life expectancy of less than 2 years
24. Pregnancy at time of enrolment
25. 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)
26. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, nitinol, tantalum or allergy to contrast agents that cannot be pre-medicated
27. 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
28. Emergency situations
29. Company employees or their immediate family members
30. Patient is under guardianship
31. Patient is participating in another clinical study for which follow-up is currently ongoing

Where it's running

• Fundação Universitaria de Cardiologia
  Porto Alegre, Rio Grande do Sul, Brazil Recruiting
• InCor - Instituto do Coração do Hospital das Clínicas da FMUSP
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: Kristine Orosz
• Email: korosz@polaresmedical.com
• Phone: +1 408 420 7446

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• MRace Implant: A first look at fixing the mitral valve to reduce regurgitation

  This single-arm study tests whether the MRace Implant and Delivery System can safely place a prosthesis to reduce severe mitral regurgitation in high-risk patients who may not be good candidates for open-heart surgery.

  Recruiting at 4 sites Polares Medical SA · Tbilisi and 3 other locations · NCT07796659

• Mitral Valve Calcification Imaging with TrueVue 3D Light Rendering

  This study tests how well three-dimensional transesophageal echocardiography with TrueVue transillumination detects mitral valve calcifications compared with CT in adults.

  Recruiting Centro Cardiologico Monzino · Milan, Milan · NCT07612553

• Tracking progression and consequences of heart valve disease

  This project will follow adults with moderate or worse valve disease to see if clinical tests and imaging can predict when their condition will get worse.

  Recruiting at 15 sites Second Affiliated Hospital, Zhejiang University, School of Medicine · Fuzhou, Fujian and 14 other locations · NCT07267117

• Surgical implantation of a polymer prosthetic mitral or aortic valve

  This will test a surgically implanted polymer heart valve to see if it is safe and works well for adults who need mitral or aortic valve replacement.

  Recruiting Mitrassist Lifesciences Limited Co., Ltd. · Shanghai, Shanghai Municipality · NCT07097740

• Abbott Cephea registry for mitral valve disease

  Collects clinical information on adults with symptomatic mitral valve disease to see how correcting the valve with the Cephea system affects outcomes for patients who might be candidates for transcatheter mitral valve replacement.

  Recruiting at 24 sites Abbott Medical Devices · Birmingham, Alabama and 23 other locations · NCT07069673

• Using the CoolCryo System to treat Atrial Fibrillation during Mitral Valve Surgery

  This study is testing whether the CoolCryo system can safely help people with atrial fibrillation feel better during mitral valve surgery.

  Recruiting at 2 sites Medinice S.A. · Bydgoszcz and 1 other locations · NCT06557616

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.