Early Feasibility Study for the Foldax Tria Aortic Heart Valve

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)