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Early Feasibility Study for the Foldax Tria Aortic Heart Valve

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03851068
Recruitment Status : Active, not recruiting
First Posted : February 22, 2019
Last Update Posted : February 25, 2022
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 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.

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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

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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)

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): NCT03851068

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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
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Principal Investigator: Frank Shannon, MD Beaumont Hospital
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Responsible Party: Foldax, Inc
ClinicalTrials.gov Identifier: NCT03851068    
Other Study ID Numbers: FOLDAX CP-001
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: February 25, 2022
Last Verified: September 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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Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction