Clinical Research Directory

Inclusion Criteria: * Is 45 years or older * Provide written informed consent prior to trial procedures after standard of care studies and tests indicate that the patient needs aortic valve replacement * Agrees to attend all follow-up assessments for up to 1 year and is willing to comply with specified follow-up evaluations for the clinical trial * Diagnosed with severe symptomatic aortic valve stenosis and/or regurgitation Exclusion Criteria: * Requires multiple valve replacement / repair * Requires emergency surgery * Has had prior valve surgery * Requires a surgical procedure outside of the cardiac area * Requires a cardiac procedure other than a CABG or root enlargement or aortic root replacement * Requires or are planning another unrelated surgery within 12 months of undergoing implantation of the study device * Has active endocarditis/myocarditis or within 3 months to the scheduled surgery * Has renal insufficiency as determined by creatinine (S-Cr) level as ≥ 1.5 mg/dl or end-stage renal disease requiring chronic dialysis at screening visit * 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 * Has acute myocardial infarction (AMI) within 30 days prior to planned valve surgery * Has life expectancy to less than 12 months * Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM), except patients who have isolated subaortic muscular hypertrophy diagnosed at the time of surgery * Diagnosed with abnormal calcium metabolism and/or hyperparathyroidism * Echocardiographic left ventricular ejection fraction \<25% * Echocardiographic evidence of an intra-cardiac thrombus or vegetation * Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery * 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 * Has prior organ transplant or is currently an organ transplant candidate * Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial * Pregnant, lactating or planning to become pregnant during the duration of participation in trial * Currently incarcerated or unable to give voluntary informed consent * Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant * Requires concomitant left ventricular assist device (LVAD) placement, Impella placement, and/or intra-aortic balloon pump * Currently has uncontrolled infection * Currently diagnosed as uncontrolled diabetes mellitus (Random BLS \> 300 mg/dl)