Early Feasibility Study for the Foldax Tria Aortic Heart Valve

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Valve Stenosis; Aortic Valve Disease
• Intervention / Treatment: Device: Foldax Tria Aortic Valve

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • St. Vincent Hospital
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Ascension Via Christi St. Francis Hospital
  • Michigan
    • Detroit, Michigan, United States, 48073
      • William Beaumont Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 84219
      • The Christ Hospital
    • Columbus, Ohio, United States, 43214
      • OhioHealth Riverside

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Is 18 years or older
2. Provide written informed consent prior to trial procedures after standard of care studies and tests indicate that the patient needs aortic valve replacement
3. 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
4. Diagnosed with symptomatic aortic valve disease (stenosis and/or regurgitation) where aortic valve replacement is recommended based on pre-operative evaluations

Exclusion Criteria:

1. Requires multiple valve replacement / repair
2. Requires emergency surgery
3. Has had prior valve surgery
4. Requires a surgical procedure outside of the cardiac area
5. Requires a cardiac procedure other than a CABG or root enlargement
6. Requires or are planning another unrelated surgery within 12 months of undergoing implantation of the study device
7. Has active endocarditis/myocarditis or within 3 months to the scheduled surgery
8. 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
9. 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
10. Has acute myocardial infarction (Ml) within 30 days prior to planned valve surgery
11. Has life expectancy to less than 12 months
12. Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM), except patients who have isolated subaortic muscular hypertrophy diagnosed at the time of surgery
13. Diagnosed with abnormal calcium metabolism and/or hyperparathyroidism
14. Echocardiographic left ventricular ejection fraction <25%
15. Echocardiographic evidence of an intra-cardiac thrombus or vegetation
16. Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery
17. 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
18. Has prior organ transplant or is currently an organ transplant candidate
19. Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial
20. Pregnant, lactating or planning to become pregnant during the duration of participation in trial
21. Currently incarcerated or unable to give voluntary informed consent
22. Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant
23. Requires concomitant left ventricular assist device (LVAD) placement, Impella placement, and/or intra-aortic balloon pump
24. Tests positive for an active infection with SARS-CoV-2 (COVID-19)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tria Aortic Valve; Patients receiving the Foldax Tria Aortic Valve	Device: Foldax Tria Aortic Valve; Aortic Valve Replacement

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Foldax, Inc
• Investigators: Principal Investigator: Frank Shannon, MD, Beaumont Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2019
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 14, 2019
• First Submitted That Met QC Criteria: February 20, 2019
• First Posted (Actual): February 22, 2019

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Aortic Valve Disease
• Other Study ID Numbers: FOLDAX CP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes