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Transcatheter Mitral Valve Repair Device
Transcatheter Mitral Valve Repair for Mitral Regurgitation (EXPLORE FMR Trial)
N/A
Waitlist Available
Research Sponsored by Polares Medical SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up device success is measured at 30 days, at 6 and 12 months, and at 2 - 5 years post-intervention
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new device called the PLAR Implant and Delivery System, which is designed to fix a leaky heart valve without open-heart surgery. It is aimed at patients who are too high-risk for traditional surgery. The device works by helping the heart valve close properly, reducing leaks and improving heart function.
Who is the study for?
This trial is for adults with severe functional mitral regurgitation who are at high surgical risk but can undergo the procedure, as determined by a heart team. They must have an STS score under 10%, be in NYHA Functional Class III or IV, and able to attend follow-ups. Exclusions include severe other valve issues, certain heart conditions, recent heart attacks or surgeries, infections, thrombosis risks, very low ejection fraction (<30%), renal insufficiency requiring dialysis, and life expectancy under 2 years.
What is being tested?
The PLAR Implant and Delivery System is being tested for safety and feasibility in treating severe functional mitral regurgitation. Up to 10 patients will receive this treatment in a single-arm study across up to four centers in North America with five years of follow-up.
What are the potential side effects?
Potential side effects may include complications from the transcatheter mitral valve repair procedure such as bleeding, infection risk related to any invasive procedure, potential damage to surrounding cardiac structures during implantation or device malfunction over time.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days, at 6 and 12 months, and at 2 - 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days, at 6 and 12 months, and at 2 - 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of all-cause mortality
Incidence of change from baseline to moderate or less mitral regurgitation (Grade 2+ or less) as evaluated by 2D TTE
Secondary study objectives
Device success rate per MVARC 2 definitions (all must be present for success)
Patient success rate per MVARC2 definitions (all must be present for success)
Procedure success rate per MVARC2 definitions
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single-arm study of PLAR Implant and Delivery SystemExperimental Treatment1 Intervention
All enrolled patients will receive the study device
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Mitral Regurgitation (MR) is commonly treated through medical management, surgical repair, or replacement of the mitral valve. Medical management includes the use of diuretics, beta-blockers, and ACE inhibitors to reduce symptoms and prevent complications.
Surgical options, such as mitral valve repair or replacement, aim to restore proper valve function and improve blood flow. The PLAR Implant and Delivery System, a type of mitral valve repair, involves the implantation of a device to correct the faulty valve mechanism.
This is crucial for MR patients as it directly addresses the underlying issue of valve incompetence, thereby improving cardiac function, reducing symptoms, and enhancing quality of life.
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Who is running the clinical trial?
Polares Medical SALead Sponsor
5 Previous Clinical Trials
33 Total Patients Enrolled
Laura A BrentonStudy DirectorPolares Medical
5 Previous Clinical Trials
563 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a current infection or endocarditis.You have had surgery on your mitral valve in the past.You have had a heart transplant in the past.Your blood pressure in the pulmonary artery is too high.You have very poor kidney function or need dialysis.You cannot have a transesophageal echocardiography (TEE) or MDCT scan for medical reasons.You have a serious problem with the tricuspid valve in your heart.You have a serious problem with your heart valve.You have a serious condition called mitral annulus calcification.You have a specific condition in the front part of your mitral valve, like flail, prolapse, or heavy calcification.You have a vena cava filter implanted in your body.Your femoral veins have severe bends and hardening.Your STS Score is less than 10%.There is evidence of blood clots in your heart or major veins in your legs.Your heart's pumping ability is less than 30%.You have been treated for heart disease within the last 30 days and are still experiencing symptoms.You had a heart attack and needed treatment less than 30 days before the study.You have certain heart conditions like amyloidosis or hypertrophic cardiomyopathy.You had a stomach ulcer or bleeding in the stomach in the last 90 days.You had a stroke less than 180 days before the study.You are experiencing severe heart failure at the time of enrolling in the study.You have unstable blood pressure and need help from medication or a machine to support your heart.You have a medical condition that is expected to reduce your life expectancy to less than 2 years.You are allergic to aspirin, heparin, ticlopidine, clopidogrel, certain metals, or contrast agents that can't be treated before the study.You have severe mitral regurgitation, as confirmed by a type of heart test called transesophageal echocardiography (TEE) within the past 90 days.You have a serious memory problem or condition that makes it hard for you to understand and make decisions about the trial, live on your own, or recover from the procedure.You have a high risk of complications from traditional mitral valve surgery because of certain heart conditions, but you are still eligible for the study if a team of heart specialists agrees.You have severe heart problems classified as New York Heart Association Functional Class III or IV.Women who could get pregnant have tested negative for pregnancy.You have a history of blood clotting problems, low white blood cell count, low red blood cell count, or low platelet count.
Research Study Groups:
This trial has the following groups:- Group 1: Single-arm study of PLAR Implant and Delivery System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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