MR-ace Implant for Mitral Regurgitation
(EXPLORE-MRace Trial)
What You Need to Know Before You Apply
What is the purpose of 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
Are You a Good Fit for This Trial?
This trial is for adults (21+) with moderate to severe mitral valve regurgitation who still have symptoms despite being on the best possible medications. Participants must be considered high risk but able to undergo surgery, and not suitable for other approved minimally invasive treatments.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- MR-ace Implant and Delivery System
Trial Overview
The study tests a new device called the MR-ace Implant and Delivery System, which replaces part of the mitral valve to reduce leaking. All participants receive this implant and are followed up regularly over five years to check its effectiveness and safety.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
treatment with the study device
Find a Clinic Near You
Who Is Running the Clinical Trial?
Polares Medical SA
Lead Sponsor
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