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Functional Mitral RegurgitationNCT04679714

EXPLORE FMR: Early Feasibility Study of the PLAR Implant and Delivery System to Treat Functional Mitral Regurgitation

A study testing Transcatheter mitral valve repair (PLAR Implant and Delivery System) in people with Functional Mitral Regurgitation, run by Polares Medical SA at 1 site in Brazil.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

An early feasibility study to evaluate the safety and feasibility of the PLAR Implant and Delivery System to treat severe functional mitral regurgitation and to gather preliminary data on its performance thereby providing guidance for future clinical development. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Functional Mitral Regurgitation
What is being tested?
Transcatheter mitral valve repair (PLAR Implant and Delivery System)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteBrazil
Study dates
30 Apr 2021to Dec 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years of age or older
  • Greater than moderate functional mitral regurgitation (Grade 3+ or higher) as confirmed by transesophageal echocardiography (TEE) within 90 days prior to study procedure
  • Patient must present with an STS Score less than 10%
  • 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
  • New York Heart Association (NYHA) Functional Class III or IV
  • Patient willing to participate in study and provide signed IRB/EC-approved informed consent
  • Treating physician and patient agree that patient is able to return for all required post-procedure follow-up visits

Who cannot join

  • Severe tricuspid regurgitation
  • Severe aortic stenosis or insufficiency
  • Severe mitral annulus calcification
  • Diseased mitral anterior leaflet such as flail / prolapse/ heavy calcification
  • Implanted vena cava filter
  • Femoral veins with severe angulation and calcification
Show all 31Show fewer
  • Contraindication for transesophageal echocardiography (TEE) or MDCT scan
  • Active infection or endocarditis
  • Previous mitral valve surgery
  • Prior orthotopic heart transplantation
  • Pulmonary artery systolic hypertension > 70mmHg
  • Evidence of intra-cardiac, inferior vena cava (IVC) or femoral venous thrombus
  • Left ventricular ejection fraction (LVEF) < 30%
  • Implant or revision of any pacing device < 30 days prior to intervention
  • Symptomatic coronary artery disease treated < 30 days prior to study procedure
  • Myocardial infarction requiring intervention < 30 days prior to study procedure
  • Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis), hypertrophic or restrictive cardiomyopathies, and constrictive pericarditis
  • Active peptic ulcer or upper gastrointestinal bleeding < 90 days prior to study procedure
  • Stroke < 180 days prior to study procedure
  • Severe renal insufficiency (creatinine > 3.0 mg/dL) or patient requiring dialysis
  • Cardiogenic shock at time of enrolment
  • Hemodynamic instability requiring inotropic support or mechanical heart assistance
  • Concurrent medical condition with a life expectancy of less than 2 years
  • Pregnancy at time of enrolment
  • History of bleeding diathesis or coagulopathy or leukopenia (WBC < 3,000 mcL) or acute anemia (Hb < 9 g/dL) or thrombocytopenia (platelets < 50,000 cells mcL)
  • Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, nitinol, tantalum or allergy to contrast agents that cannot be pre-medicated
  • Severe dementia or lack of capacity due to conditions that result in either inability to provide informed consent for the trial/procedure, prevent independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up assessments
  • Emergency situations
  • Company employees or their immediate family members
  • Patient is under guardianship
  • Patient is participating in another clinical study for which follow-up is currently ongoing

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • InCor - Instituto do Coração do Hospital das Clínicas da FMUSP

    São Paulo, São Paulo, 05403-900

Other trials in Brazil

About this study

Official title: Early Feasibility Study of the PLAR Implant and Delivery System to Treat Functional Mitral Regurgitation (EXPLORE FMR)

An early feasibility study to evaluate the safety and feasibility of the PLAR Implant and Delivery System to treat severe functional mitral regurgitation and to gather preliminary data on its performance thereby providing guidance for future clinical development. The study is a single-arm registry with the last follow-up visit at 5 years post-intervention. The study will enroll up to 10 patients at one (1) center in Brazil.

Read the detailed description

Percutaneous approaches to treat MR promise to provide a sufficient reduction in MR without the risks typically associated with open heart surgery.

Furthermore there is an unmet clinical need for patients with severe MR who are refused or denied surgery due to high risk. Percutaneous therapy provides a novel alternative treatment option for these patients with the aim of reducing morbidity and mortality over and above current medical therapy. The Polares Medical PLAR Implant and Delivery System is a catheter-based technology designed to permanently implant a prosthesis using a transvenous / transseptal approach to augment the posterior mitral valve leaflet and improve coaptation with the anterior leaflet. Approved edge-to-edge repair has already been shown to be a viable alternative for high risk MR patients. However treatment with these devices is limited to specific anatomies and often requires multiple devices which increases clinical risk, adds to procedural time, and can result in residual MR. The PLAR Implant and Delivery System has been designed to overcome and mitigate some of these shortfalls.

Being tested
Transcatheter mitral valve repair (PLAR Implant and Delivery System)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcatheter mitral valve repair (PLAR Implant and Delivery System)Device

    Also called TMVr

    The PLAR Implant is placed on the mitral valve posterior annulus using its delivery system via femoral vein access and a transeptal puncture

Study groups in NCT04679714
Study groupRoleWhat they receive
Single-arm study of PLAR Implant and Delivery SystemExperimentalAll enrolled patients will receive the study device
Receives: Device: Transcatheter mitral valve repair (PLAR Implant and Delivery System)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of all-cause mortality

    Primary safety outcome

    Measured: 30-days follow-up

  2. Incidence of change from baseline to moderate or less mitral regurgitation (Grade 2+ or less) as evaluated by 2D TTE Primary performance endpoint

    Primary performance endpoint

    Measured: 30-days follow-up

Secondary outcomes (5)

  1. Rate of major safety events as defined by MVARC2 definitions

    Secondary safety endpoint

    Measured: Follow-up at 30 days, at 6 and 12 months, and at 2, 3, 4 and 5 years

  2. Technical success rate per MVARC2 definitions

    All of the following must be present for technical success:

    • Absence of procedure mortality
    • Successful access, delivery and retrieval of investigation delivery system
    • Successful deployment and correct positioning of intended implant(s)
    • Freedom from emergency surgery/re-intervention related to device or access procedure

    Measured: Technical success is measured immediately following the procedure

  3. Procedure success rate per MVARC2 definitions

    Both of the following must be present for procedure success:

    • Device success
    • Absence of major device or procedure-related serious adverse events as below:
    • Death
    • Stroke
    • Life-threatening bleed
    • Major vascular complication
    • Major cardiac structural complication
    • Stage 2 or 3 AKI
    • MI or coronary ischemia requiring PCI or CABG
    • Shock, heart or respiratory failure requiring IV vasopressors, mechanical intervention or prolonged intubation
    • Valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention

    Measured: Procedure success is measured at 30 days follow-up

  4. Device success rate per MVARC 2 definitions

    All of the following must be present for device success:

    • Absence of procedure mortality or stroke
    • Proper placement and positioning of device
    • Freedom from unplanned re-intervention related to device or access procedure • Continued intended safety and performance of the device as below:
    • No evidence of structural or functional failure
    • No device technical failure issues/complications
    • MR reduction to moderate or less without stenosis

    Measured: Device success is measured at 30 days, at 6 and 12 months, and at 2, 3, 4, and 5 years follow-up

  5. Patient success rate per MVARC2 definitions

    All of the following must be present for patient success:

    • Device success
    • Patient returned to pre-procedure setting
    • No rehospitalization or reintervention for mitral regurgitation or heart failure
    • Functional improvement from baseline by one or more NYHA class
    • 6MWT improvement from baseline by 50 metres or more

    Measured: Patient success is measured at 12 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2020
  2. Study start30 Apr 2021
  3. Primary completionMar 2022 (estimated)
  4. Study completionDec 2026 (estimated)

Why it stopped: product refinement

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Model description
Single-arm registry
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04679714
Sponsor's protocol ID
202004
Status last verified
Aug 2026
First submitted
8 Dec 2020
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: Clinical trial results will be shared with investigators once study is enrolled and trial data is prepared for presentation at a medical conference or for publication in a medical journal.

Questions about this trial

What is this clinical trial studying?

A study testing Transcatheter mitral valve repair (PLAR Implant and Delivery System) in people with Functional Mitral Regurgitation, run by Polares Medical SA at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of all-cause mortality (time frame: 30-days follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04679714.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.

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