What side effects are associated with this type of intervention?

Common treatments for mitral regurgitation, including surgical repair and transcatheter mitral valve repair (TMVR), can have side effects such as bleeding, infection, arrhythmias, stroke, vascular complications, device malfunction, and residual mitral regurgitation. Medical management, often used alongside these procedures, may cause hypotension, renal dysfunction, and electrolyte imbalances.

What prior FDA approvals exist?

The FDA has approved several treatments for Mitral Regurgitation, particularly focusing on mitral valve repair and replacement. One notable device is the MitraClip, a transcatheter mitral valve repair device that has been approved for patients with primary and secondary mitral regurgitation who are at high surgical risk. Additionally, surgical mitral valve repair and replacement procedures have long been established as effective treatments. These interventions aim to restore proper valve function and improve patient outcomes. The PLAR Implant and Delivery System, currently under study, represents a novel approach in this therapeutic area, potentially offering a less invasive option for patients with severe functional mitral regurgitation.

What other types of research exist?

Promising alternatives to the PLAR Implant and Delivery System for mitral regurgitation patients in 2024 include: 1) Transcatheter Mitral Valve Repair (TMVR) devices such as the MitraClip, which has been widely adopted and continues to evolve with new iterations. 2) The PASCAL system, another TMVR device that offers a different mechanism for edge-to-edge repair. 3) The Tendyne Transcatheter Mitral Valve Replacement, which is a fully repositionable and retrievable valve replacement option. 4) The Cardioband system, which allows for annular reduction and reshaping of the mitral valve. These alternatives are supported by ongoing clinical trials and recent approvals, indicating their potential efficacy and safety for patients.

← Back to Search

Transcatheter Mitral Valve Repair Device

Transcatheter Mitral Valve Repair for Mitral Regurgitation (EXPLORE FMR Trial)

Q: What is the mechanism of action of this treatment?

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.

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

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

Do I qualify?Apply below to find out

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.