early feasibility study for the foldax tria aortic heart valve

Conditions: Aortic Valve Disease; Aortic Valve Stenosis

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.

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.

Eligibility 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)