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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

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.

Condition or disease Intervention/treatment Phase
Mitral Valve Disease Mitral Valve Stenosis Mitral Valve Failure Device: Foldax TRIA Mitral Valve Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
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
Official Title: Early Feasibility Study for the Foldax TRIA Mitral Heart Valve Replacement Investigational Device Exemption
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2025

Arm Intervention/treatment
Experimental: TRIA Mitral Valve
Patients receiving the Foldax Mitral Valve
Device: Foldax TRIA Mitral Valve
Mitral Valve Replacement




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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

  6. 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

  7. 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

  8. 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.

  9. 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.

  10. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04717570


Contacts
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Contact: Carlyn Sander, BS, BSN 352-359-2355 carlyn.sander@foldax.com

Locations
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United States, Indiana
St. Vincent Hospital Recruiting
Carmel, Indiana, United States, 46260
Contact: Cheree Slusher    317-582-6115    cheree.slusher@ascension.org   
Principal Investigator: Dave Heimansohn, MD         
United States, Kansas
Ascension Via Christi St. Francis Recruiting
Wichita, Kansas, United States, 67226
Contact: Lindsey Steele, R.T.    316-219-4125    lindsey.steele@cckheart.com   
Principal Investigator: Bassem Chahab, MD         
Sub-Investigator: Brett Grizzell, MD         
United States, Ohio
The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Susie Frakes, BSN    513-585-1777    belinda.frakes@thechristhospital.com   
Principal Investigator: Geoffrey Answini, MD         
Sponsors and Collaborators
Foldax, Inc
Investigators
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Study Chair: Frank Shannon, MD Beaumont Hospital
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Responsible Party: Foldax, Inc
ClinicalTrials.gov Identifier: NCT04717570    
Other Study ID Numbers: Foldax CP-002
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: June 8, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Mitral Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases