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EXPLORE MRace (GE): Early Feasibility Experience of Posterior Leaflet Restoration to Reduce Mitral Regurgitation Using the MRace Implant (EXPLORE_MRace)

27. august 2026 opdateret af: Polares Medical SA

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Georgien
      • Tbilisi, Georgien, 0112
        • Rekruttering
        • Israeli-Georgian Medical Research Clinic Healthycore
        • Ledende efterforsker:
          • Irakli Gogorishvili, MD
        • Kontakt:
      • Tbilisi, Georgien, 0159
        • Rekruttering
        • LLC "Emergency Cardilogy Center by Acad. G. Chapidze"
        • Ledende efterforsker:
          • Alexander Aladashvili, MD
        • Kontakt:
      • Tbilisi, Georgien, 0159
        • Rekruttering
        • Ltd Tbilisi Heart and Vascular Clinic
        • Ledende efterforsker:
          • Tamaz Shaburishvili, MD
        • Kontakt:
      • Tbilisi, Georgien, 0186
        • Rekruttering
        • Ltd Tbilisi Heart Centre
        • Ledende efterforsker:
          • Archil Chukhrukidze, MD
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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) < 20%
  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 Subject requiring dialysis
  21. Cardiogenic shock at time of enrollment
  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 or breastfeeding at time of enrollment
  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. Emergency situations
  28. 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
  29. Company employees or their immediate family members
  30. Subject is under guardianship
  31. Subject is participating in another clinical study for which follow-up is currently ongoing.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: MRace arm
Enkeltarmsundersøgelse af MRace-implantat- og indføringssystem til behandling af alvorlig mitralregurgitation Alle tilmeldte patienter vil modtage undersøgelsesanordningen
Enhed: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Primary safety outcome
Tidsramme: 30-days follow-up
Incidence of all-cause mortality following treatment with the MRace Implant and Delivery System
30-days follow-up
Primary Performance Endpoint
Tidsramme: 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
30-days follow-up

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Polares Medical SA

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

23. maj 2022

Primær færdiggørelse (Anslået)

1. december 2032

Studieafslutning (Anslået)

1. december 2032

Datoer for studieregistrering

Først indsendt

27. august 2026

Først indsendt, der opfyldte QC-kriterier

27. august 2026

Først opslået (Faktiske)

1. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 202202

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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