- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06113354
EXPLORE MRace: Early Feasibility Experience of Posterior Leaflet Restoration to Reduce Mitral Regurgitation Using the MRace Implant (EXPLORE MRace)
Early Feasibility Experience of Posterior Leaflet Restoration to Reduce Mitral Regurgitation Using the MRace Implant (EXPLORE MRace)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Stephen Kao
- Phone Number: +1 650 776 8433
- Email: skao@polaresmedical.com
Study Locations
-
-
-
São Paulo, Brazil, 05403-900
- INCOR - Instituto do Coração do Hospital das Clínicas da FMUSP
-
Contact:
- Alexandre Abizaid, MD
-
Principal Investigator:
- Alexandre Abizaid, MD
-
Contact:
- Fabio Sandoli de Brito, MD
-
Principal Investigator:
- Fabio Sandoli de Brito, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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) < 30%
- 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 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 at time of enrolment
- 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
- 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
- Emergency situations
- Company employees or their immediate family members
- Patient is under guardianship
- Patient is participating in another clinical study for which follow-up is currently ongoing
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MRace Arm
Single-arm study of MRace Implant and Delivery System to treat severe mitral regurgitation All enrolled patients will receive the study device
|
The MRace Implant is placed mitral valve posterior annulus using its delivery system via femoral vein access and a transeptal puncture Other Names: TMVr |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of all-cause mortality following treatment with the MRace Implant and Delivery System
Time Frame: 30-days follow-up
|
Primary safety outcome
|
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 2D TTE
Time Frame: 30-days follow-up
|
Primary performance endpoint
|
30-days follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of major safety events as defined by MVARC2 definitions
Time Frame: Follow-up at 30 days, at 6 and 12 months, and at 2, 3, 4 and 5 years
|
Secondary safety endpoint
|
Follow-up at 30 days, at 6 and 12 months, and at 2, 3, 4 and 5 years
|
Technical success rate per MVARC2 definitions
Time Frame: Technical success is measured immediately following the procedure
|
All of the following must be present for technical success: Absence of procedure mortality Successful access, delivery and retrieval of investigation delivery system Successful deployment and correct positioning of intended implant(s) Freedom from emergency surgery/re-intervention related to device or access procedure |
Technical success is measured immediately following the procedure
|
Procedure success rate per MVARC2 definitions
Time Frame: Procedure success is measured at 30 days follow-up
|
Both of the following must be present for procedure success: Device success Absence of major device or procedure-related serious adverse events as below: Death Stroke Life-threatening bleed Major vascular complication Major cardiac structural complication Stage 2 or 3 AKI MI or coronary ischemia requiring PCI or CABG Shock, heart or respiratory failure requiring IV vasopressors, mechanical intervention or prolonged intubation Valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention |
Procedure success is measured at 30 days follow-up
|
Device success rate per MVARC 2 definitions
Time Frame: Device success is measured at 30 days, at 6 and 12 months, and at 2, 3, 4, and 5 years follow-up
|
All of the following must be present for device success: Absence of procedure mortality or stroke Proper placement and positioning of device Freedom from unplanned re-intervention related to device or access procedure Continued intended safety and performance of the device as below: No evidence of structural or functional failure No device technical failure issues/complications MR reduction to moderate or less without stenosis |
Device success is measured at 30 days, at 6 and 12 months, and at 2, 3, 4, and 5 years follow-up
|
Patient success rate per MVARC2 definitions
Time Frame: Patient success is measured at 12 months follow-up
|
All of the following must be present for patient success: Device success Patient returned to pre-procedure setting No rehospitalization or reintervention for mitral regurgitation or heart failure • Functional improvement from baseline by one or more NYHA class 6MWT improvement from baseline by 50 metres or more |
Patient success is measured at 12 months follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Roberto deFilippo, Polares Medical
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202302
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mitral Valve Disease
-
Abbott Medical DevicesActive, not recruitingMitral Valve Disease | Damaged Mitral Valve | Malfunctioning Mitral Heart Valve | Mitral Valve ReplacementUnited States
-
University Hospital, Basel, SwitzerlandRecruitingMitral Valve Disease | Mitral Valve SurgerySwitzerland
-
Caisson Interventional LLCActive, not recruitingMitral Regurgitation | Valve Disease, Heart | Valve Heart Disease | Mitral Valve Disease | Mitral Valve Failure | Mitral DiseaseUnited States
-
InnovHeartActive, not recruitingHeart Valve Diseases | Mitral Regurgitation | Valve Heart Disease | Mitral Valve Disease | Mitral DiseaseLithuania, Denmark, Hungary
-
Academisch Medisch Centrum - Universiteit van Amsterdam...RecruitingMitral Regurgitation | Surgery | Cardiac Valve Disease | Mitral Valve Disease | Mitral Valve Surgery | Mitral Valve RepairNetherlands
-
Eric Y. Yang, MD PhDUnknownMitral Regurgitation | Mitral Valve Insufficiency | Mitral Valve Prolapse | Ventricular Remodeling | Mitral Valve Disease | Degenerative Mitral Valve Disease | Chronic Mitral Disease | Myxomatous Mitral Valve DegenerationUnited States
-
Abbott Medical DevicesRecruitingCardiovascular Diseases | Heart Valve Diseases | Mitral Regurgitation | Mitral Valve Insufficiency | Valve Disease, Heart | Mitral Insufficiency | Functional Mitral Regurgitation | Degenerative Mitral Valve DiseaseUnited States, Canada
-
Foldax, IncActive, not recruitingMitral Regurgitation | Mitral Valve Insufficiency | Mitral Valve Disease | Mitral StenosisIndia
-
Edwards LifesciencesNot yet recruitingMitral Regurgitation | Mitral Valve Disease | Mitral Stenosis
-
Pipeline MedicalActive, not recruitingMitral Valve Regurgitation | Degenerative Mitral Valve DiseaseSerbia, Georgia, Paraguay
Clinical Trials on Transcatheter mitral valve repair (MRace Implant and Delivery System)
-
Polares Medical SAPolares Medical, Inc.Not yet recruitingFunctional Mitral Regurgitation
-
Polares Medical SAPolares Medical, Inc.Not yet recruitingDegenerative Mitral Valve Disease
-
Hangzhou Valgen Medtech Co., LtdNot yet recruitingMitral Valve Insufficiency
-
Second Affiliated Hospital, School of Medicine,...Recruiting
-
Michele De BonisCompletedMitral Valve RegurgitationItaly
-
Hangzhou Valgen Medtech Co., LtdRecruitingMitral Regurgitation FunctionalChina
-
Hangzhou Valgen Medtech Co., LtdEnrolling by invitationDegenerative Mitral Valve DiseaseChina
-
Shanghai Zhongshan HospitalNot yet recruitingMitral Regurgitation
-
Shanghai Shenqi Medical Technology Co., LtdActive, not recruitingFunctional Mitral RegurgitationChina
-
Neovasc Inc.Active, not recruitingMitral Valve RegurgitationUnited States, Canada, Belgium