A Prospective, Multicenter, Single-Arm Study to Support the Clinical Evidence Base for MRace as a Treatment Option for FMR Patients With Complex M-TEER Anatomies (AU)

NCT07757698 | Not Yet Recruiting DMC

• 1 other identifier: 202603
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

A pilot study to evaluate the safety and performance of the MRace System to treat severe mitral regurgitation and to gather 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 15 patients at 1 center in Australia

Conditions

Mitral Valve (MV) Regurgitation

Keywords

Mitral Valve Regurgitation; MV Regurgitation; MVR; Secondary Mitral Regurgitation; Secondary MR; Functional Mitral Regurgitation; Functional MR; FMR; MR; TMVR; Transcather Mitral Valve Repair; M-TEER

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint

  The primary safety endpoint is all-cause mortality at 30 days post-index procedure.

  30 days post-index procedure

• Primary Performance Endpoint

  Improvement from baseline to moderate or less mitral regurgitation (Grade 2+ or less) at 30 days as evaluated by 2D transthoracic echocardiography.

  30 days post-index procedure

Study Arms (1)

MRace Arm

EXPERIMENTAL

Single-arm study of MRace System to treat severe mitral regurgitation All enrolled patients will receive the study device

Device: Transcatheter mitral valve repair

Interventions

Transcatheter mitral valve repair DEVICE

The MRace Implant is placed mitral valve posterior annulus using its delivery system via femoral vein access and a transeptal puncture

MRace Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has symptomatic moderate-to-severe to severe functional mitral regurgitation despite stable doses of optimized guideline-directed medical therapy (GDMT) per the Local Heart Team.
• a. Note: In the 30 days prior to performing screening assessments, no new GDMT medications should be introduced, and current doses should be stable (i.e. no decrease of \> 50% or increase of \> 100%) excluding diuretics. Any changes beyond this range would not be considered stable GDMT.
• Functional MR graded 3+ or higher by transthoracic echocardiography (TTE) within 60 days prior to study procedure as evaluated by the sponsor's Echo Core Lab.
• New York Heart Association (NYHA) Functional Class II, III or ambulatory IV heart failure
• Patient must present with an STS Score less than 10% and deemed by the Local Heart Team to be at high risk but operable for mitral valve surgery.
• The Local Heart Team deems the patient's anatomy to be unsuitable for M-TEER.
• years of age or older.
• Native mitral valve geometry and size is compatible with the Polares MRace system.
• Anatomy is suitable for transfemoral transseptal access with the Polares MRace system.
• Patient is willing to participate in study and provides signed EC-approved informed consent.
• Treating physician and patient agree that patient is able to return for all required post-procedure follow-up visits.
• Patient is approved by an independent Patient Eligibility Committee (PEC) which will confirm the presence of at least of the following one complex anatomical feature:
• Atrial Functional MR with coaptation depth \<5-mm
• PLM length \< 10 mml
• Gap-Width \> 10-18 mm

You may not qualify if:

• Echocardiographic parameters (any of the following, assessed by the Echo Core Lab)
• Left ventricular ejection fraction (LVEF) \< 30%
• Pulmonary artery systolic pressure (PASP) \> 70mmHg or \> 2/3 SBP (Systolic Blood Pressure)
• Left Ventricle End Diastolic Volume (LV EDV) \> 200mL for males; \>130mL for females
• Left Ventricle End Systolic Volume (LV ESV) \> 70 mL
• Left Ventricle End Diastolic Diameter (LV EDD) \> 70 mm
• Left Ventricle End Systolic Diameter (LV ESD) \> 55 mm
• Anatomical features as per assessment by Local Heart Team and confirmed by the Patient Eligibility Committee
• IC \> 4 5mm
• PML \> 14 mm
• MR width \> 18 mm
• Severe MAC
• PM height \< 20 mm
• AML or PML prolapse
• Mean gradient \> 5 mmHg

Sponsors & Collaborators

• Polares Medical SA: lead

MeSH Terms

Conditions

Gastroesophageal Reflux; Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-arm registry

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 1, 2032
• Study Completion (Estimated): December 1, 2032
• Last Updated: August 11, 2026

Record last verified: 2026-08