Early Feasibility Study for the Foldax Tria Aortic Heart Valve

• ClinicalTrials.gov Identifier: NCT03851068
• Recruitment Status: Active, not recruiting
• First Posted: February 22, 2019
• Last Update Posted: February 25, 2022
• Sponsor: Foldax, Inc
• Information provided by (Responsible Party): Foldax, Inc

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Aortic Valve Disease; Aortic Valve Stenosis	Device: Foldax Tria Aortic Valve	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Early Feasibility Study for the Foldax Tria Aortic Heart Valve
• Actual Study Start Date: June 18, 2019
• Estimated Primary Completion Date: December 2024
• Estimated Study Completion Date: December 2026

Arms and Interventions

Arm	Intervention/treatment
Experimental: Tria Aortic Valve; Patients receiving the Foldax Tria Aortic Valve	Device: Foldax Tria Aortic Valve; Aortic Valve Replacement

Outcome Measures

Primary Outcome Measures :

1. Primary Safety Endpoints: Objective Performance Criteria for Flexible Heart Valve Events Assessments [ Time Frame: 12 months following patient enrollment completion ]
   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
2. Primary Safety Endpoints: Surgical Valve Events Rate Assessment [ Time Frame: 12 months following patient enrollment completion ]
   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
3. Primary Effectiveness Endpoint: Hemodynamic Performance Assessment [ 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.
4. Primary Effectiveness Endpoint: 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.

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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)

Contacts and Locations

Locations

United States, Indiana

St. Vincent Hospital

Indianapolis, Indiana, United States, 46290

United States, Kansas

Ascension Via Christi St. Francis Hospital

Wichita, Kansas, United States, 67214

United States, Michigan

William Beaumont Hospital

Detroit, Michigan, United States, 48073

United States, Ohio

The Christ Hospital

Cincinnati, Ohio, United States, 84219

OhioHealth Riverside

Columbus, Ohio, United States, 43214

Sponsors and Collaborators

Foldax, Inc

Investigators

• Principal Investigator: Frank Shannon, MD; Beaumont Hospital

More Information

• Responsible Party: Foldax, Inc
• ClinicalTrials.gov Identifier: NCT03851068
• Other Study ID Numbers: FOLDAX CP-001
• First Posted: February 22, 2019
• Last Update Posted: February 25, 2022
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Additional relevant MeSH terms:

Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction