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Evaluation of Safety and Efficacy of the BACE™ Device in the Treatment of Functional Mitral Valve Regurgitation [FMR (BACE)

Primary Purpose

Functional Mitral Regurgitation

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BACE Device
Sponsored by
Phoenix Cardiac Devices, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Mitral Regurgitation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Functional Mitral Valve Regurgitation (FMR) of moderate to severe grade (2 to 4 as per the American College of Cardiology and American Heart Association 2006 Classification of Mitral regurgitation evaluation)
  • Symptomatic- NYHA Class II to IV
  • Left Ventricular Ejection Fraction (LVEF) 25%-50%
  • Normal mitral valve leaflets without any abnormalities and damage
  • Subject is willing and available to return for study follow-up
  • Surgical approach is the treatment option
  • Ability of the subject or legal representative to understand and provide signed consent for participating in the study

Exclusion Criteria:

  • Known hypersensitivity or allergy to the device materials
  • History or presence of rheumatic heart disease
  • Structural abnormality of the mitral valve (e.g. flail leaflets, ruptured or elongated chordae, prolapsed valve, perforated valve leaflets)
  • Severe pulmonary hypertension, defined by pulmonary artery systolic (PAS) pressure greater than or equal to 60 mm Hg
  • Grade 4 diastolic dysfunction of left ventricle on ECHO, with no change by hemodynamic maneuvers.
  • ST segment [of an electrocardiogram] (ST) segment elevation myocardial infarction [MI] within 30 days of enrollment in the study; non ST segment elevation Myocardial Infarction (MI) within 7days of enrollment in the study
  • Currently enrolled in another investigational drug or device study
  • Subjects with intra-operative [correlate to pre-op measurement end diastolic dimension] heart circumference outside of offered BACE device size ranges [21 to 41 cm]
  • Previous mitral valve surgery or other previous cardiac surgery that would preclude proper placement of the BACE
  • Abnormal coronary or cardiac anatomy such that the device could not be placed without interfering with those anatomical structures
  • Abnormalities in the mitral valve leaflets that would necessitate mitral valve reconstruction or replacement
  • Prior Coronary Artery Bypass Graft (CABG) surgery
  • Acute active infection
  • Active peptic ulcer
  • History of IV drug abuse
  • Chronic renal failure requiring dialysis
  • Creatinine > 2.5 mg/dl
  • Open chest surgery contraindication [e.g., acute respiratory distress, endocarditis, myocarditis, pericarditis]
  • Immune suppression therapy including corticosteroids
  • Subjects with chronic connective tissue disease
  • Investigator judgment that body habitus or sternal anatomy precludes pericardial access
  • Females who are pregnant or lactating
  • Life expectancy of < 12 months due to conditions other than cardiac status

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Control and Test

    Arm Description

    Pre-implantation and Post-implantation of BACE device

    Outcomes

    Primary Outcome Measures

    Reduction in MR grade to MR grade 1+ or less
    Reduction in Mitral Valve Regurgitation (MR) grade to MR grade 1+ or less after the implantation of the BACE Device as measured by echocardiography.

    Secondary Outcome Measures

    Durability of or improvement in MR grade over the follow-up period as measured by echocardiography; profiles of the grades in MR based on ECHO at each time point will be plotted for each subject with description of individual percentage change
    Durability of or improvement in MR grade over the follow-up period as measured by echocardiography
    Improvement in cardiac functionality as assessed by the NYHA functional class
    Improvement in cardiac functionality as assessed by the New York Heart Association (NYHA) functional class
    Improvement in cardiac functionality as assessed by the 6-minute walk
    Improvement in cardiac functionality as assessed by the 6-minute walk
    Improvement in cardiac functionality
    Improvement in cardiac functionality as assessed by the Minnesota Living with Heart Failure questionnaire
    All device and surgery-related averse events
    All device and surgery-related averse events (listed above) and other adverse events over the course of the study will be tabulated

    Full Information

    First Posted
    February 17, 2016
    Last Updated
    September 14, 2020
    Sponsor
    Phoenix Cardiac Devices, Inc.
    Collaborators
    Toronto General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02701972
    Brief Title
    Evaluation of Safety and Efficacy of the BACE™ Device in the Treatment of Functional Mitral Valve Regurgitation [FMR
    Acronym
    BACE
    Official Title
    Evaluation of Safety and Efficacy of the Basal Annuloplasty of the Cardia Externally (BACE™) [Basal Annuloplasty of the Cardia Externally] Device in the Treatment of Functional Mitral Valve Regurgitation [FMR]
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2016 (undefined)
    Primary Completion Date
    June 30, 2021 (Anticipated)
    Study Completion Date
    September 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Phoenix Cardiac Devices, Inc.
    Collaborators
    Toronto General Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The preclinical and clinical evidence of safety and efficacy with the BACE device (concept and feasibility) paved the way for the evaluation of the BACE device in this prospective, multi-center, single-arm, self-controlled study for safety and efficacy in the treatment of functional MR in a maximum of 60 adult subjects. The primary efficacy endpoint will be reduction of MR grade to 1+ or less from the baseline MR grade through the 6 month study period. Primary safety endpoint will be freedom from major device and surgery-related adverse events for the duration of the 6 month follow up period. Patients will be followed up to two years.
    Detailed Description
    The primary objective of this study is to assess the safety and efficacy of the BACE device for the treatment of FMR. Secondary objective is to assess the ease of deployment of the BACE device Study Population: Since this study is to assess the safety and efficacy of a new device, with no control arm or comparator, the number of subjects enrolled will be a maximum of 60. Approximately 8-10 sites are expected to be included in the study. The subject population is adults of 18 to 80 years of age, either gender, with FMR as specified in the inclusion and exclusion criteria.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Functional Mitral Regurgitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    BACE device implant
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    35 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control and Test
    Arm Type
    Experimental
    Arm Description
    Pre-implantation and Post-implantation of BACE device
    Intervention Type
    Device
    Intervention Name(s)
    BACE Device
    Intervention Description
    Implanted BACE device
    Primary Outcome Measure Information:
    Title
    Reduction in MR grade to MR grade 1+ or less
    Description
    Reduction in Mitral Valve Regurgitation (MR) grade to MR grade 1+ or less after the implantation of the BACE Device as measured by echocardiography.
    Time Frame
    Two years
    Secondary Outcome Measure Information:
    Title
    Durability of or improvement in MR grade over the follow-up period as measured by echocardiography; profiles of the grades in MR based on ECHO at each time point will be plotted for each subject with description of individual percentage change
    Description
    Durability of or improvement in MR grade over the follow-up period as measured by echocardiography
    Time Frame
    Two years
    Title
    Improvement in cardiac functionality as assessed by the NYHA functional class
    Description
    Improvement in cardiac functionality as assessed by the New York Heart Association (NYHA) functional class
    Time Frame
    Two years
    Title
    Improvement in cardiac functionality as assessed by the 6-minute walk
    Description
    Improvement in cardiac functionality as assessed by the 6-minute walk
    Time Frame
    Two years
    Title
    Improvement in cardiac functionality
    Description
    Improvement in cardiac functionality as assessed by the Minnesota Living with Heart Failure questionnaire
    Time Frame
    Two years
    Title
    All device and surgery-related averse events
    Description
    All device and surgery-related averse events (listed above) and other adverse events over the course of the study will be tabulated
    Time Frame
    Two years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Functional Mitral Valve Regurgitation (FMR) of moderate to severe grade (2 to 4 as per the American College of Cardiology and American Heart Association 2006 Classification of Mitral regurgitation evaluation) Symptomatic- NYHA Class II to IV Left Ventricular Ejection Fraction (LVEF) 25%-50% Normal mitral valve leaflets without any abnormalities and damage Subject is willing and available to return for study follow-up Surgical approach is the treatment option Ability of the subject or legal representative to understand and provide signed consent for participating in the study Exclusion Criteria: Known hypersensitivity or allergy to the device materials History or presence of rheumatic heart disease Structural abnormality of the mitral valve (e.g. flail leaflets, ruptured or elongated chordae, prolapsed valve, perforated valve leaflets) Severe pulmonary hypertension, defined by pulmonary artery systolic (PAS) pressure greater than or equal to 60 mm Hg Grade 4 diastolic dysfunction of left ventricle on ECHO, with no change by hemodynamic maneuvers. ST segment [of an electrocardiogram] (ST) segment elevation myocardial infarction [MI] within 30 days of enrollment in the study; non ST segment elevation Myocardial Infarction (MI) within 7days of enrollment in the study Currently enrolled in another investigational drug or device study Subjects with intra-operative [correlate to pre-op measurement end diastolic dimension] heart circumference outside of offered BACE device size ranges [21 to 41 cm] Previous mitral valve surgery or other previous cardiac surgery that would preclude proper placement of the BACE Abnormal coronary or cardiac anatomy such that the device could not be placed without interfering with those anatomical structures Abnormalities in the mitral valve leaflets that would necessitate mitral valve reconstruction or replacement Prior Coronary Artery Bypass Graft (CABG) surgery Acute active infection Active peptic ulcer History of IV drug abuse Chronic renal failure requiring dialysis Creatinine > 2.5 mg/dl Open chest surgery contraindication [e.g., acute respiratory distress, endocarditis, myocarditis, pericarditis] Immune suppression therapy including corticosteroids Subjects with chronic connective tissue disease Investigator judgment that body habitus or sternal anatomy precludes pericardial access Females who are pregnant or lactating Life expectancy of < 12 months due to conditions other than cardiac status
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Vivek Rao, MD PhD
    Organizational Affiliation
    Toronto General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Evaluation of Safety and Efficacy of the BACE™ Device in the Treatment of Functional Mitral Valve Regurgitation [FMR

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