EXPLORE MRace (GE): Early Feasibility Experience of Posterior Leaflet Restoration to Reduce Mitral Regurgitation Using the MRace Implant (EXPLORE_MRace)
27 augusti 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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
Studietyp
Interventionell
Inskrivning (Beräknad)
100
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Tbilisi, Georgien, 0112
- Rekrytering
- Israeli-Georgian Medical Research Clinic Healthycore
-
Huvudutredare:
- Irakli Gogorishvili, MD
-
Kontakt:
- Gvantsa Dughashvili, MD
- Telefonnummer: +995 599 509 003
- E-post: dughashviligvantsaa@gmail.com
-
Tbilisi, Georgien, 0159
- Rekrytering
- LLC "Emergency Cardilogy Center by Acad. G. Chapidze"
-
Huvudutredare:
- Alexander Aladashvili, MD
-
Kontakt:
- Tinatin Kavtaradze, MD
- Telefonnummer: +995 599 147 799
- E-post: tinatinkavtaradze11@gmail.com
-
Tbilisi, Georgien, 0159
- Rekrytering
- Ltd Tbilisi Heart and Vascular Clinic
-
Huvudutredare:
- Tamaz Shaburishvili, MD
-
Kontakt:
- Teona Zirakashvili, MD
- Telefonnummer: + 995 555 291 018
- E-post: zirakashvilit@gmail.com
-
Tbilisi, Georgien, 0186
- Rekrytering
- Ltd Tbilisi Heart Centre
-
Huvudutredare:
- Archil Chukhrukidze, MD
-
Kontakt:
- Ketevan Gabunia, MD
- Telefonnummer: +995 599 577 977
- E-post: kgabunia@tbhc.ge
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: MRace arm
Enarmsstudie av MRace Implant and Delivery System för att behandla svår mitralisuppstötning Alla inskrivna patienter kommer att få studieanordningen
|
The MRace Implant is placed mitral valve posterior annulus using its delivery system via femoral vein access and a transeptal puncture
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Primary safety outcome
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
23 maj 2022
Primärt slutförande (Beräknad)
1 december 2032
Avslutad studie (Beräknad)
1 december 2032
Studieregistreringsdatum
Först inskickad
27 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
27 augusti 2026
Första postat (Faktisk)
1 september 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
1 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 202202
Läkemedels- och apparatinformation, studiedokument
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