Health TrialsbyHealthPanel

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

ConditionMitral Regurgitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorPolares Medical SA

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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 groups

15 Participants
are divided into 1 treatment group
Group A: TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Primary Safety Endpoint

All-cause mortality

Time frame
30 days post procedure
2

Primary Performance Endpoint

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

Time frame
30 days post procedure

Secondary outcomes

1

Secondary Safety Endpoint

Rate of major safety events using MVACR2 classification

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

Secondary Performance Endpoint

MVARC2 success criteria

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Polares Medical SA

Lead sponsor

Source ClinicalTrials.gov
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