Early Feasibility Study for the Foldax Tria Aortic Heart Valve

Sponsor
Foldax, Inc (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03851068
Collaborator
(none)
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Study Details

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
  • Device: Foldax Tria Aortic Valve
N/A

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
Anticipated 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 :
Jun 18, 2019
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 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 [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 [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 [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 [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 [5 years following patient enrollment]

    Assessment of patient experiencing a stroke verified by imaging and or physical exam

  2. Secondary Endpoint: Transient Ischemic Attack [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 [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 [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 [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 [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 [30 days post discharge]

    Patient readmission to the hospital post discharge measured by date/time

  8. Secondary Endpoint: Hemolysis screen [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) [12 months post procedure]

    Change in QOL as measured by the Kansas City Cardiomyopathy Questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 St. Vincent Hospital Indianapolis Indiana United States 46290
2 Ascension Via Christi St. Francis Hospital Wichita Kansas United States 67214
3 William Beaumont Hospital Detroit Michigan United States 48073
4 The Christ Hospital Cincinnati Ohio United States 84219
5 OhioHealth Riverside Columbus Ohio United States 43214

Sponsors and Collaborators

  • Foldax, Inc

Investigators

  • Principal Investigator: Frank Shannon, MD, Beaumont Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Foldax, Inc
ClinicalTrials.gov Identifier:
NCT03851068
Other Study ID Numbers:
  • FOLDAX CP-001
First Posted:
Feb 22, 2019
Last Update Posted:
Feb 25, 2022
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
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:

Study Results

No Results Posted as of Feb 25, 2022