EFS of Posterior Leaflet Replacement to Reduce Mitral Regurgitation (United States)

NCT07517588 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 202501
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this early feasibility clinical trial is to learn if the device MR-ace Implant and Delivery System works in patients with moderate or severe mitral valve regurgitation. It will also learn about the safety of the device MR-ace Implant and Delivery System. The main questions it aims to answer are: Does implanting the MR-ace device reduce the symptoms of mitral regurgitation? Does the device reduce the the leak through your mitral valve? Participants will: Be implanted with the device Visit the clinic for checkups and tests at 30 days, 6 months, 12 months, and 2, 3, 4 and 5 years following your procedure Complete a quality of life survey

Conditions

Mitral Regurgitation

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint

  All-cause mortality

  30 days post procedure

• Primary Performance Endpoint

  Reduction in mitral regurgitation (Grade 2+ or less) as evaluated by 2D transthoracic echocardiography.

  30 days post procedure

Secondary Outcomes (2)

• Secondary Safety Endpoint

  30 days, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years post procedure

• Secondary Performance Endpoint

  30 days, 6 months, 12 months, 2 yrs, 3 years, 4 years, and 5 years post procedure

Study Arms (1)

Treatment

EXPERIMENTAL

treatment with the study device

Device: MR-ace Implant and Delivery System

Interventions

MR-ace Implant and Delivery System DEVICE

This study device uses a transcatheter procedure through your leg veins to place the MRace implant and cover the posterior leaflet of your own mitral valve.

Treatment

Eligibility Criteria

• Age: 21 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 maximally tolerated guideline directed medical therapy (GDMT) per the Local Heart Team.
• 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 (using a scale of 0 to 4+) 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 unsuitable for commercially approved transcatheter mitral valve therapies
• 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 IRB/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

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) \> 200 mL
• Left Ventricle End Systolic Volume (LV ESV) \> 140 mL
• Left Ventricle End Diastolic Diameter (LV EDD) \> 70 mm
• Left Ventricle End Systolic Diameter (LV ESD) \> 55 mm
• Severe Right Ventricle (RV) dysfunction as per assessment by Local Heart Team or Eligibility Committee .
• Severe tricuspid regurgitation.
• Severe aortic stenosis or insufficiency.
• Severe mitral annulus calcification.
• Diseased mitral anterior and/or posterior leaflet, such as flail, / prolapse, or/ heavy moderate to severe calcification.
• Barlow's disease.
• Presence of an implanted vena cava filter or any other device (e.g. ASD closure device) that may interfere with femoral vein access or delivery system access to the mitral valve.
• Contraindication for transesophageal echocardiography (TEE) or MDCT scan

Sponsors & Collaborators

• Polares Medical SA: lead

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

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

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 8, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2031
• Last Updated: April 8, 2026

Record last verified: 2026-04