EFS of Posterior Leaflet Replacement to Reduce Mitral Regurgitation (United States)
ConditionMitral Regurgitation
Trial statusNot yet recruiting
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
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
Treatments tested in this trial
- MR-ace Implant and Delivery System
Treatment groups
15 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov