Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve

Inclusion Criteria

• Inclusion Criteria - Subjects will be required to meet all inclusion criteria:
• Male or female, age 18 years or older
• Has aortic stenosis or stenosis-insufficiency of an aortic valve requiring a planned replacement as indicated in the preoperative evaluation
• Is scheduled to undergo planned aortic valve replacement with or without concomitant coronary bypass surgery
• Provide written informed consent
• Geographically stable and agrees to attend follow-up assessments until all subjects have completed 5 years of follow up

Exclusion Criteria

• Exclusion Criteria - Subjects will not be eligible for trial participation if any of the following criteria are present:
• Pure aortic insufficiency
• Requires emergency surgery
• Previous aortic valve replacement
• Had prior mitral, tricuspid or pulmonic valve surgery, which included implant of a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ
• Requires multiple valve replacement/repair
• Requires a surgical procedure outside of the cardiac area (e.g., vascular endarterectomy, vascular bypass, tumor removal)
• Aneurysm of the aortic root and/or ascending aorta requiring surgical intervention
• Active endocarditis/myocarditis or endocarditis/ myocarditis within 3 months prior to the scheduled AVR surgery
• Myocardial infarction (MI) within thirty (30) days prior to valve replacement surgery
• Renal insufficiency as determined by creatinine ≥ 2.5 mg/dL at screening or end-stage renal disease requiring chronic dialysis
• Hyperparathyroidism
• MRI or CT-scan confirmed cerebrovascular accident (CVA), or transient ischemic attack (TIA) within 6 months (180 days) of the procedure
• Presence of non-cardiac disease limiting life expectancy to less than 12 months
• Hypertrophic obstructive cardiomyopathy (HOCM)
• Left ventricular ejection fraction ≤ 25%
• Documented history of substance (drug or alcohol) abuse within the last 5 years
• Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation
• Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to the procedure
• Pregnancy, lactation, or planning to become pregnant;
• Currently incarcerated or unable to give voluntary informed consent
• Leucopenia (WBC < 3.5x 103/µL), or acute anemia (Hgb < 10.0 gm/dL or 6 mmol/L), or thrombocytopenia (platelet count < 50x 103/µL), or history of bleeding diathesis or coagulopathy
• History of myxomatous disease/connective tissue disorders (e.g., Marfan's Syndrome)
• Current or recent participation (within 6 weeks prior to surgery) in an investigational drug or device trial
• Intra-operative Exclusion Criteria
• Anatomic variances which contraindicate implant of the trial valve, such as:
• anomalous coronary arteries
• annular deformation or extensive calcification of the annulus or aortic root which cannot be removed
• significant calcium on the anterior mitral leaflet
• pronounced septal calcification
• position of coronary ostia relative to Model 8300ACD valve that would result in obstruction of blood flow
• Available devices are not suitably sized for the subject's annulus