Back to resultsEarly Feasibility Study for the Foldax TRIA Mitral Heart Valve Replacement (FOLDAX)
Primary Purpose
Mitral Valve Disease, Mitral Valve Stenosis, Mitral Valve Failure
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Foldax TRIA Mitral Valve
Sponsored by
About this trial
This is an interventional treatment trial for Mitral Valve Disease
Eligibility 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- Patients who have withdrawn after implantation may not re-enter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.
Sites / Locations
- St. Vincent Hospital
- Ascension Via Christi St. Francis
- The Christ Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TRIA Mitral Valve
Arm Description
Patients receiving the Foldax Mitral Valve
Outcomes
Primary Outcome Measures
Primary Safety Endpoints
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
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
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
Number of Participants with Stroke
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
Assessment of patient having a TIA as verified by imaging and or physical exam
Number of Participants with Migration of the TRIA valve
Assessment of patient experiencing valve migration as verified by imaging, procedure, or physical exam.
ICU Duration of Stay
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
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
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
Patient readmission to the hospital post discharge measured by date/time
Post Procedure length of stay
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)
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
Change in patients activity tolerance as documented by a 6 Minute Walk Test assessed by distance traveled after 6 minutes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04717570
Brief Title
Early Feasibility Study for the Foldax TRIA Mitral Heart Valve Replacement
Acronym
FOLDAX
Official Title
Early Feasibility Study for the Foldax TRIA Mitral Heart Valve Replacement Investigational Device Exemption
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foldax, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Disease, Mitral Valve Stenosis, Mitral Valve Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All patients will receive the study device
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TRIA Mitral Valve
Arm Type
Experimental
Arm Description
Patients receiving the Foldax Mitral Valve
Intervention Type
Device
Intervention Name(s)
Foldax TRIA Mitral Valve
Intervention Description
Mitral Valve Replacement
Primary Outcome Measure Information:
Title
Primary Safety Endpoints
Description
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.
Time Frame
12 months following patient enrollment completion
Title
Primary Effectiveness Endpoints- Change in Hemodynamic Performance
Description
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.
Time Frame
12 months following patient enrollment completion
Title
Clinical Effectiveness: Change in New York Heart Association Assessment
Description
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.
Time Frame
12 months following patient enrollment completion
Secondary Outcome Measure Information:
Title
Number of Participants with Stroke
Description
Assessment of patient experiencing a stroke (ex; ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage, or other) verified by imaging and or physical exam
Time Frame
5 years following patient enrollment
Title
Number of Participants with Transient Ischemic Attack
Description
Assessment of patient having a TIA as verified by imaging and or physical exam
Time Frame
5 years following patient enrollment
Title
Number of Participants with Migration of the TRIA valve
Description
Assessment of patient experiencing valve migration as verified by imaging, procedure, or physical exam.
Time Frame
5 years following patient enrollment
Title
ICU Duration of Stay
Description
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.
Time Frame
30 days post patient enrollment
Title
Ventilation Time
Description
Ventilation time in hours defined as arrival time/date in recovery in hours and minutes to date and time extubated in hours and minutes
Time Frame
30 days post patient enrollment
Title
New Onset Atrial Fibrillation
Description
New/post-operative atrial fibrillation - confirmed on ECG after closure during initial or subsequent admission or at one-year review
Time Frame
12 months post patient enrollment
Title
Readmission within 30 days of discharge
Description
Patient readmission to the hospital post discharge measured by date/time
Time Frame
30 days post patient discharge date
Title
Post Procedure length of stay
Description
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.
Time Frame
30 days post patient enrollment
Title
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description
Change in QOL as measured by the KCCQ. Scores are measured from 0-100, in hich higher scores reflect better health status.
Time Frame
12 months post patient enrollment
Title
Six Minute Walk Test
Description
Change in patients activity tolerance as documented by a 6 Minute Walk Test assessed by distance traveled after 6 minutes
Time Frame
12 months post patient enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Shannon, MD
Organizational Affiliation
Beaumont Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
St. Vincent Hospital
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Ascension Via Christi St. Francis
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Early Feasibility Study for the Foldax TRIA Mitral Heart Valve Replacement
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