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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 weeks
Treatment ~ Varies
Follow Up ~30 days, at 6 and 12 months, and at 2 - 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days, at 6 and 12 months, and at 2 - 5 years for reporting.

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 more

Awards & 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.

Find a Location

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

PLAR Implant and Delivery System (Transcatheter Mitral Valve Repair Device) Clinical Trial Eligibility Overview. Trial Name: NCT04666467 — N/A
Mitral Regurgitation Research Study Groups: Single-arm study of PLAR Implant and Delivery System
Mitral Regurgitation Clinical Trial 2023: PLAR Implant and Delivery System Highlights & Side Effects. Trial Name: NCT04666467 — N/A
PLAR Implant and Delivery System (Transcatheter Mitral Valve Repair Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04666467 — N/A
~0 spots leftby Oct 2025