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Transcatheter Mitral Valve Repair for Mitral Regurgitation (EXPLORE FMR Trial)
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.
EXPLORE FMR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowEXPLORE FMR Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.EXPLORE FMR Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Single-arm study of PLAR Implant and Delivery System
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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"
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."
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."
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