Early Feasibility Study for the Foldax Tria Aortic Heart Valve

Study Overview
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Brief Summary
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The purpose of this study is to conduct the initial clinical investigation of the Foldax Polymer Aortic 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
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The Foldax Polymer Aortic Valve is indicated as a replacement for a diseased, damaged, or malfunctioning native aortic 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 40 patients. These patients will be followed up to 5 years after implantation.

Official Title
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Early Feasibility Study for the Foldax Tria Aortic Heart Valve

Conditions
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Aortic Valve Disease, Aortic Valve Stenosis

Intervention / Treatment
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* Device: Foldax Tria Aortic Valve


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is 18 years or older Provide written informed consent prior to trial procedures after standard of care studies and tests indicate that the patient needs aortic valve replacement Agrees to attend all follow-up assessments for up to 5 years and is willing to comply with specified follow-up evaluations for the FOLDAX Clinical trial Diagnosed with symptomatic aortic valve disease (stenosis and/or regurgitation) where aortic valve replacement is recommended based on pre-operative evaluations Exclusion Criteria: Requires multiple valve replacement / repair Requires emergency surgery Has had prior valve surgery Requires a surgical procedure outside of the cardiac area Requires a cardiac procedure other than a CABG or root enlargement Requires or are planning another unrelated surgery within 12 months of undergoing implantation of the study device Has active endocarditis/myocarditis or within 3 months to the scheduled surgery Has renal insufficiency as determined by creatinine (S-Cr) level as ≥ 1.5 mg/dl or endstage renal disease requiring chronic dialysis at screening visit Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months (90 days) prior to planned valve surgery Has acute myocardial infarction (Ml) within 30 days prior to planned valve surgery Has life expectancy to less than 12 months Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM), except patients who have isolated subaortic muscular hypertrophy diagnosed at the time of surgery Diagnosed with abnormal calcium metabolism and/or hyperparathyroidism Echocardiographic left ventricular ejection fraction <25% Echocardiographic evidence of an intra-cardiac thrombus or vegetation Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery Documented leukopenia (WBC < 4.0 x 103/µL), acute anemia (Hgb < 10.0 gm/dl or 6 mmol/L), thrombocytopenia (platelet count < 100 x103/µL) or history of bleeding diathesis or coagulopathy Has prior organ transplant or is currently an organ transplant candidate Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial Pregnant, lactating or planning to become pregnant during the duration of participation in trial Currently incarcerated or unable to give voluntary informed consent Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant Requires concomitant left ventricular assist device (LVAD) placement, Impella placement, and/or intra-aortic balloon pump Tests positive for an active infection with SARS-CoV-2 (COVID-19)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tria Aortic Valve<br>Patients receiving the Foldax Tria Aortic Valve | Device: Foldax Tria Aortic Valve<br>* Aortic Valve Replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoints: Objective Performance Criteria for Flexible Heart Valve Events Assessments | The adverse events consistent with the Objective Performance Criteria (OPC), for flexible heart valves will be compared to those rates defined as acceptable levels in the standard. a. Thromboembolism b. Valve Thrombosis c. Major Paravalvular leak d. Major Hemorrhage e. Endocarditis | 12 months following patient enrollment completion | 
| Primary Safety Endpoints: Surgical Valve Events Rate Assessment | The rates of other events will be compared to clinical outcomes for surgically implanted heart valves reported in the literature. a. All-caused death b. Valve related death c. Valve-related reoperation d. Valve explant e. Hemorrhage f. All-cause reoperation g. Valve-related death | 12 months following patient enrollment completion | 
| Primary Effectiveness Endpoint: Hemodynamic Performance Assessment | 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. | 12 months following patient enrollment completion | 
| Primary Effectiveness Endpoint: New York Heart Association Improvement 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. | 12 months following patient enrollment completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Endpoints: Stroke | Assessment of patient experiencing a stroke verified by imaging and or physical exam | 5 years following patient enrollment | 
| Secondary Endpoint: Transient Ischemic Attack | Assessment of patient having a TIA verified by imaging and or physical exam | 5 Years following patient enrollment | 
| Secondary Endpoint: 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. | 30 days post procedure | 
| Secondary Endpoint: 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 | 30 Days post procedure | 
| Secondary Endpoint: New Onset Atrial Fibrillation | New/post-operative atrial fibrillation - confirmed on ECG after closure during initial or subsequent admission or at one-year review | 12 Months post procedure | 
| Secondary Endpoint: Length of Stay in Hospital | Post procedure length of stay defined as the date and time in hours and minutes documented for arrival in the recovery unit to date and time in hours and minutes of discharge in hours and minutes. | 30 days post procedure | 
| Secondary Endpoint: Readmission | Patient readmission to the hospital post discharge measured by date/time | 30 days post discharge | 
| Secondary Endpoint: Hemolysis screen | Hemolysis screen is measured by blood tests including hemoglobin and liver enzyme assessments | 12 months post procedure | 
| Secondary Endpoint: Change in Quality of Life (QOL) | Change in QOL as measured by the Kansas City Cardiomyopathy Questionnaire | 12 months post procedure |