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

Primary Purpose

Degenerative Mitral Valve Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transcatheter mitral valve repair (PLAR Implant and Delivery System)
Sponsored by
Polares Medical SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Degenerative Mitral Valve Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18 years of age or older
  2. Greater than moderate degenerative mitral regurgitation (Grade 3+ or higher) as confirmed by transesophageal echocardiography (TEE) within 90 days prior to study procedure
  3. Patient must present with an STS Score less than 10%
  4. 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
  5. New York Heart Association (NYHA) Functional Class III or IV
  6. Patient willing to participate in study and provide signed IRB/EC-approved informed consent
  7. Treating physician and patient agree that patient is able to return for all required post-procedure follow-up visits

Exclusion Criteria:

  1. Severe tricuspid regurgitation
  2. Severe aortic stenosis or insufficiency
  3. Severe mitral annulus calcification
  4. Diseased mitral anterior leaflet such as flail / prolapse/ heavy calcification
  5. Implanted vena cava filter
  6. Femoral veins with severe angulation and calcification
  7. Contraindication for transesophageal echocardiography (TEE) or MDCT scan
  8. Active infection or endocarditis
  9. Previous mitral valve surgery
  10. Prior orthotopic heart transplantation
  11. Pulmonary artery systolic hypertension > 70mmHg
  12. Evidence of intra-cardiac, inferior vena cava (IVC) or femoral venous thrombus
  13. Left ventricular ejection fraction (LVEF) < 30%
  14. Implant or revision of any pacing device < 30 days prior to intervention
  15. Symptomatic coronary artery disease treated < 30 days prior to study procedure
  16. Myocardial infarction requiring intervention < 30 days prior to study procedure
  17. Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis), hypertrophic or restrictive cardiomyopathies, and constrictive pericarditis
  18. Active peptic ulcer or upper gastrointestinal bleeding < 90 days prior to study procedure
  19. Stroke < 180 days prior to study procedure
  20. Severe renal insufficiency (creatinine > 3.0 mg/dL) or patient requiring dialysis
  21. Cardiogenic shock at time of enrolment
  22. Hemodynamic instability requiring inotropic support or mechanical heart assistance
  23. Concurrent medical condition with a life expectancy of less than 2 years
  24. Pregnancy at time of enrolment
  25. 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)
  26. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, nitinol, tantalum or allergy to contrast agents that cannot be pre-medicated
  27. 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
  28. Emergency situations
  29. Company employees or their immediate family members
  30. Patient is under guardianship
  31. Patient is participating in another clinical study for which follow-up is currently ongoing

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Single-arm study of PLAR Implant and Delivery System to treat severe mitral regurgitation

    Arm Description

    All enrolled patients will receive the study device

    Outcomes

    Primary Outcome Measures

    Incidence of all-cause mortality following treatment with the PLAR Implant and Delivery System
    Primary safety outcome
    Incidence of change from severe mitral regurgitation at baseline (Grade 3+ or more) to moderate or less mitral regurgitation (Grade 2+ or less) following treatment with the PLAR Implant and Delivery System as evaluated by 2D TTE
    Primary performance endpoint

    Secondary Outcome Measures

    Rate of major safety events as defined by MVARC2 definitions
    Secondary safety endpoint
    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
    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
    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
    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

    Full Information

    First Posted
    December 8, 2020
    Last Updated
    December 21, 2020
    Sponsor
    Polares Medical SA
    Collaborators
    Polares Medical, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04679662
    Brief Title
    EXPLORE DMR: Early Feasibility Study of the PLAR Implant and Delivery System to Treat Degenerative Mitral Regurgitation
    Official Title
    Early Feasibility Study of the PLAR Implant and Delivery System to Treat Degenerative Mitral Regurgitation (EXPLORE DMR)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2021 (Anticipated)
    Primary Completion Date
    March 2022 (Anticipated)
    Study Completion Date
    December 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Polares Medical SA
    Collaborators
    Polares Medical, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    An early feasibility study to evaluate the safety and feasibility of the PLAR Implant and Delivery System to treat severe degenerative 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Degenerative Mitral Valve Disease

    7. Study Design

    Primary Purpose
    Device Feasibility
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Single-arm registry
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Single-arm study of PLAR Implant and Delivery System to treat severe mitral regurgitation
    Arm Type
    Experimental
    Arm Description
    All enrolled patients will receive the study device
    Intervention Type
    Device
    Intervention Name(s)
    Transcatheter mitral valve repair (PLAR Implant and Delivery System)
    Other Intervention Name(s)
    TMVr
    Intervention Description
    The PLAR Implant is placed mitral valve posterior annulus using its delivery system via femoral vein access and a transeptal puncture
    Primary Outcome Measure Information:
    Title
    Incidence of all-cause mortality following treatment with the PLAR Implant and Delivery System
    Description
    Primary safety outcome
    Time Frame
    30-days follow-up
    Title
    Incidence of change from severe mitral regurgitation at baseline (Grade 3+ or more) to moderate or less mitral regurgitation (Grade 2+ or less) following treatment with the PLAR Implant and Delivery System as evaluated by 2D TTE
    Description
    Primary performance endpoint
    Time Frame
    30-days follow-up
    Secondary Outcome Measure Information:
    Title
    Rate of major safety events as defined by MVARC2 definitions
    Description
    Secondary safety endpoint
    Time Frame
    Follow-up at 30 days, at 6 and 12 months, and at 2, 3, 4 and 5 years
    Title
    Technical success rate per MVARC2 definitions
    Description
    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
    Time Frame
    Technical success is measured immediately following the procedure
    Title
    Procedure success rate per MVARC2 definitions
    Description
    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
    Time Frame
    Procedure success is measured at 30 days follow-up
    Title
    Device success rate per MVARC 2 definitions
    Description
    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
    Time Frame
    Device success is measured at 30 days, at 6 and 12 months, and at 2, 3, 4, and 5 years follow-up
    Title
    Patient success rate per MVARC2 definitions
    Description
    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
    Time Frame
    Patient success is measured at 12 months follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 years of age or older Greater than moderate degenerative 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 Exclusion Criteria: 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 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Laura A Brenton
    Phone
    +1 313 919 8044
    Email
    lbrenton@polaresmedical.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Laura A Brenton
    Organizational Affiliation
    Polares Medical
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    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.

    Learn more about this trial

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

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