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Early Feasibility Study for the Foldax TRIA Mitral Heart Valve Replacement (FOLDAX)

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ClinicalTrials.gov Identifier: NCT04717570
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : June 8, 2021
Sponsor:
Information provided by (Responsible Party):
Foldax, Inc

Tracking Information
First Submitted Date  ICMJE December 14, 2020
First Posted Date  ICMJE January 22, 2021
Last Update Posted Date June 8, 2021
Actual Study Start Date  ICMJE February 1, 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2021)
  • Primary Safety Endpoints [ Time Frame: 12 months following patient enrollment completion ]
    Adverse Event (AE) rates for valve related early and late complications : thromboembolism, valve thrombosis, major hemorrhage, major paravalvular leak, endocarditis, structural valve deterioration, nonstructural valve dysfunction, valve related hemolysis, all cause death, valve related reoperation, valve explant, and valve related death. Results are visually compared to event rates reported in the literature.
  • Primary Effectiveness Endpoints- Change in Hemodynamic Performance [ Time Frame: 12 months following patient enrollment completion ]
    Hemodynamic performance parameters are mmHG mean gradient and derived Effective Orifice Area (EOA). Success is defined as clinically significant improvement in hemodynamic performance (Effective Orifice Area (EOA)) at one year based on literature reports for surgical aortic valve replacement.
  • Clinical Effectiveness: Change in New York Heart Association Assessment [ Time Frame: 12 months following patient enrollment completion ]
    Clinically significant improvement (one grade) in the New York Heart Association (NYHA) functional classification status at 365 days compared to baseline. a. Class I - No symptoms and no limitations in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. b. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. c. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100m). Comfortable only at rest. d. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
Original Primary Outcome Measures  ICMJE
 (submitted: January 15, 2021)
  • Primary Safety Endpoints [ Time Frame: 12 months following patient enrollment completion ]
    Adverse Event (AE) rates for valve related early and late complications : thromboembolism, valve thrombosis, major hemorrhage, major paravalvular leak, endocarditis, structural valve deterioration, nonstructural valve dysfunction, valve related hemolysis, all cause death, valve related reoperation, valve explant, and valve related death. Results are visually compared to event rates reported in the literature.
  • Primary Effectiveness Endpoints- Hemodynamic Performance [ Time Frame: 12 months following patient enrollment completion ]
    Hemodynamic performance parameters are mmHG mean gradient and derived Effective Orifice Area (EOA). Success is defined as clinically significant improvement in hemodynamic performance (Effective Orifice Area (EOA)) at one year based on literature reports for surgical aortic valve replacement.
  • Clinical Effectiveness: New York Heart Association Improvement Assessment [ Time Frame: 12 months following patient enrollment completion ]
    Clinically significant improvement (one grade) in the New York Heart Association (NYHA) functional classification status at 365 days compared to baseline. a. Class I - No symptoms and no limitations in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. b. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. c. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100m). Comfortable only at rest. d. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2021)
  • Number of Participants with Stroke [ Time Frame: 5 years following patient enrollment ]
    Assessment of patient experiencing a stroke (ex; ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage, or other) verified by imaging and or physical exam
  • Number of Participants with Transient Ischemic Attack [ Time Frame: 5 years following patient enrollment ]
    Assessment of patient having a TIA as verified by imaging and or physical exam
  • Number of Participants with Migration of the TRIA valve [ Time Frame: 5 years following patient enrollment ]
    Assessment of patient experiencing valve migration as verified by imaging, procedure, or physical exam.
  • ICU Duration of Stay [ Time Frame: 30 days post patient enrollment ]
    Length of stay in the ICU post valve implantation defined as arrival time/date in hours and minutes to transfer to floor time/date in hours and minutes.
  • Ventilation Time [ Time Frame: 30 days post patient enrollment ]
    Ventilation time in hours defined as arrival time/date in recovery in hours and minutes to date and time extubated in hours and minutes
  • New Onset Atrial Fibrillation [ Time Frame: 12 months post patient enrollment ]
    New/post-operative atrial fibrillation - confirmed on ECG after closure during initial or subsequent admission or at one-year review
  • Readmission within 30 days of discharge [ Time Frame: 30 days post patient discharge date ]
    Patient readmission to the hospital post discharge measured by date/time
  • Post Procedure length of stay [ Time Frame: 30 days post patient enrollment ]
    l. Post procedure length of stay defined as the time/date documented for arrival in the recovery unit to date/ time of discharge in hours and minutes.
  • Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: 12 months post patient enrollment ]
    Change in QOL as measured by the KCCQ. Scores are measured from 0-100, in hich higher scores reflect better health status.
  • Six Minute Walk Test [ Time Frame: 12 months post patient enrollment ]
    Change in patients activity tolerance as documented by a 6 Minute Walk Test assessed by distance traveled after 6 minutes
Original Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2021)
  • Stroke [ Time Frame: 5 years following patient enrollment ]
    Assessment of patient experiencing a stroke (ex; ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage, or other) verified by imaging and or physical exam
  • Transient Ischemic Attack [ Time Frame: 5 years following patient enrollment ]
    Assessment of patient having a TIA as verified by imaging and or physical exam
  • Migration of the TRIA valve [ Time Frame: 5 years following patient enrollment ]
    Assessment of patient experiencing valve migration as verified by imaging, procedure, or physical exam.
  • ICU Duration of Stay [ Time Frame: 30 days post patient enrollment ]
    Length of stay in the ICU post valve implantation defined as arrival time/date in hours and minutes to transfer to floor time/date in hours and minutes.
  • Ventilation Time [ Time Frame: 30 days post patient enrollment ]
    Ventilation time in hours defined as arrival time/date in recovery in hours and minutes to date and time extubated in hours and minutes
  • New Onset Atrial Fibrillation [ Time Frame: 12 months post patient enrollment ]
    New/post-operative atrial fibrillation - confirmed on ECG after closure during initial or subsequent admission or at one-year review
  • Readmission within 30 days of discharge [ Time Frame: 30 days post patient discharge date ]
    Patient readmission to the hospital post discharge measured by date/time
  • Post Procedure length of stay [ Time Frame: 30 days post patient enrollment ]
    l. Post procedure length of stay defined as the time/date documented for arrival in the recovery unit to date/ time of discharge in hours and minutes.
  • Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: 12 months post patient enrollment ]
    Change in QOL as measured by the KCCQ
  • Six Minute Walk Test [ Time Frame: 12 months post patient enrollment ]
    Change in patients activity tolerance as documented by a 6 Minute Walk Test assessed by distance traveled after 6 minutes
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Feasibility Study for the Foldax TRIA Mitral Heart Valve Replacement
Official Title  ICMJE Early Feasibility Study for the Foldax TRIA Mitral Heart Valve Replacement Investigational Device Exemption
Brief Summary The purpose of this study is to conduct the initial clinical investigation of the Foldax Polymer Mitral Valve to collect evidence on the device's safety and performance. The study is anticipated to confirm successful clinical safety and clinical effectiveness with significant improvements in clinical hemodynamic performance.
Detailed Description The Foldax Polymer Mitral Valve is indicated as a replacement for a diseased, damaged, or malfunctioning native mitral heart valve via open heart surgery. This is a first in human study conducted under US FDA's Early Feasibility Investigational Device Exemption and will enroll up to 15 patients. These patients will be followed up to 5 years after implantation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
All patients will receive the study device
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Mitral Valve Disease
  • Mitral Valve Stenosis
  • Mitral Valve Failure
Intervention  ICMJE Device: Foldax TRIA Mitral Valve
Mitral Valve Replacement
Study Arms  ICMJE Experimental: TRIA Mitral Valve
Patients receiving the Foldax Mitral Valve
Intervention: Device: Foldax TRIA Mitral Valve
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 15, 2021)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Is 18 years or older
  • Is a candidate for mitral valve replacement with cardiopulmonary bypass
  • Is a candidate for mitral valve replacement due to:
  • Moderate to severe mitral valve stenosis,
  • Moderate to severe mitral valve regurgitation, or
  • Moderate to severe mixed mitral stenosis/regurgitation
  • Able to withstand short term anticoagulation
  • Willing and able to comply with protocol requirements

Exclusion Criteria:

  • Prior mitral valve surgery for valve replacement or valve repair (this does NOT include percutaneous interventions i.e. Mitraclip, chordal replacement)
  • Requires emergency surgery
  • Requires other planned surgery within 12 months of valve replacement
  • Active endocarditis or active myocarditis
  • Acute preoperative neurological deficit defined as neurological deficit < 3 months prior to enrollment
  • Non-cardiac illness resulting in a life expectancy of less than 12 months
  • Enrolled in another investigational device or drug study (enrolled patients may not enroll in other studies)
  • Myocardial infarction, or severe cardiac adverse event which has not returned to baseline for at least 30-days prior to enrollment
  • Aortic aneurysm or other medical condition that creates a higher than usual risk of surgical complications
  • Renal or hepatic failure
  • Hematological disorders, patients must not have a hematocrit of <30%, hemoglobin <10 g/dL, platelet count of <100,000 cells/µL, or WBC <4,000 cells/µL; coagulation profile must not be outside of normal limits
  • Patients who are prisoners or mentally ill
  • Patients who are pregnant or expect to become pregnant in the 12 months following implantation, or are lactating
  • Has a positive test result for COVID-19 virus (baseline or preoperative)
  • Patients who have withdrawn after implantation may not re-enter
  • Intraoperatively it is determined that the patient anatomy is not compatible with the device.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Carlyn Sander, BS, BSN 352-359-2355 carlyn.sander@foldax.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04717570
Other Study ID Numbers  ICMJE Foldax CP-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Foldax, Inc
Study Sponsor  ICMJE Foldax, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Frank Shannon, MD Beaumont Hospital
PRS Account Foldax, Inc
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP