Early Feasibility Study for the Foldax Tria Aortic Heart Valve

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.

Inclusion criteria

• Is 18 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 5 years and is willing to comply with specified follow-up evaluations for the FOLDAX Clinical trial
• Diagnosed with symptomatic aortic valve disease (stenosis and/or regurgitation) where aortic valve replacement is recommended based on pre-operative evaluations

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
• 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 endstage 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 (Ml) 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
• Tests positive for an active infection with SARS-CoV-2 (COVID-19)