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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
High surgical risk for conventional mitral repair or replacement due to morphological criteria (e.g. leaflet or annulus calcifications), but operable, as assessed by the local heart team comprised of a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in treating mitral valve disease and heart failure
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

EXPLORE FMR Trial Summary

This trial is testing a new way to treat severe mitral regurgitation (leakage of blood backwards through the heart) that may provide guidance for future clinical development. Up to 10 patients will be enrolled at 4 centers in North America, with follow-up visits at 5 years post-intervention.

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.Check my eligibility
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.See study design
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.

EXPLORE FMR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
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.

EXPLORE FMR Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

EXPLORE FMR 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

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What results is this experiment attempting to ascertain?

"The primary aim of this clinical trial, observed over a month-long period, is to assess the all-cause mortality rate. Secondary objectives encompass patient success in accordance with pre-supplied MVARC2 definitions; these include returning patients to their original state without rehospitalization or reapplication of mitral regurgitation treatments, functional improvement measured by NYHA class metrics and 50 metre improvements on 6MWT tests from baseline. Additionally, technical successes are defined as successful device access/delivery/retrieval procedures alongside proper deployment and positioning of intended implants; freedom from emergency surgery related to devices or access procedure required for success. Device"

Answered by AI

Is enrollment for this research still ongoing?

"As found on the website clinicaltrials.gov, recruitment for this study is currently underway; it was originally published on April 1st 2021 and recently updated February 1st 2022."

Answered by AI

How many participants are presently eligible for this research endeavor?

"Yes, according to information on clinicaltrials.gov this trial is still recruiting participants and was initially posted on April 1st 2021. The study requires 10 volunteers across a single site, with the data being most recently updated on February 1st 2022."

Answered by AI
~0 spots leftby Mar 2025