Isolated Surgical Aortic Valve Replacement in Low Risk AS Patients

Inclusion Criteria:

1. All study participants must meet the following inclusion criteria 1. Severe,calcific aortic stenosis with the following criteria:

• Jet velocity ≥4.0 m/s or mean gradient ≥ 40 mmHg OR

• AVA ≤1.0 cm2 or AVA index ≤ 0.6 cm2/m2 Note: Qualifying TTE must be within 90days prior to randomization AND 2. NYHA class ≥ II OR Exercisee test that demonstrates a limited exercisecapacity, abnormal blood pressure response, or arrhythmia OR Asymptomatic patientswith LVEF <50%

2. The Heart Team agrees that the surgical mortality risk is less than 4% according toSTS-PROM. The Heart Team's assessment should include evaluation of overall clinicalstatus and comorbidities that may not be adequately captured by risk calculatorssuch as STS-PROM, in addition to the risk score itself.

3. The patient has been informed of the nature of the study, agrees to its provisionsand has provided written informed consent as approved by certified review board.

Exclusion Criteria:

Candidates will be excluded from the study if any of the following conditions are present:

1. History of cardiovascular surgery or thoracotomy

2. Pre-existing other valvular disease, coronary artery disease or aortic diseaserequired intervention Note: interventions for arrhythmia or root enlargement are notconsidered exclusionary.

3. Heart Team assessment that chest abnormalities or significant frailty would preventsafe SAVR.

4. Native aortic annulus size unsuitable for sizes the currently approved and marketedSAVR or TAVR based on preoperative 3D-CT image analysis.

5. Iliofemoral vessel characteristics that whould preclude safe insertion of theintroducer sheath.

6. Evidence of an acute myocardial infarction or PCI ≤ 30 days before randomization

7. Aortic valve is unicuspid

8. Severe aortic regurgitation (>3+)

9. Severe mitral regurgitation (>3+) or ≥ moderate stenosis

10. Severe tricuspid regurgitation (>3+) or ≥ moderate stenosis

11. Pre-existing mechanical or bioprosthetic valve in any position.

12. Complex coronary artery disease:

13. Heart Team assessment that CABG is recommended at the time of SAVR

14. Heart Team assessment that optimal revascularization cannot be performed

15. Symptomatic carotid or vertebral artery disease or treatment of carotid stenosiswithin 30 days of randomization

16. Leukopenia (WBC < 3000 cell/mL), Thrombocytopenia (Plt < 50,000 cell/mL), history ofbleeding diathesis or coagulopathy.

17. Hemodynamic or respiratory instability requiring inotropic support, mechanicalventilation or mechanical heart assistance within 30 days of randomization

18. Hypertrophic cardiomyopathy with obstruction (HOCM)

19. Ventricular dysfunction with LVEF < 30%

20. Cardiac imaging (echo, CT, and/or MRI) evidence of intracardiac mass, thrombus orvegetation

21. Inability to tolerate or condition precluding treatment withantithrombotic/anticoagulation therapy during or after the valve implant procedure

22. Stroke or transient ischemic attack (TIA) within 90 days of randomization

23. Renal insufficiency (eGFR < 30 ml/min per the Cockcroft-Gault formula) and/or renalreplacement therapy

24. Active bacterial endocarditis within 180 days of randomization

25. Severe lung disease (FEV1 < 50% predicted) or currently on home oxygen

26. Severe pulmonary hypertension (e.g., PA systolic pressure ≥ 2/3 systemic pressure)

27. History of cirrhosis or active liver disease

28. Significant abdominal or thoracic aortic disease (such as porcelain aorta, aneurysm,severe calcification, aortic coarctation, etc.) that would preclude cannulation andaortotomy for SAVR or safe passage of the delivery system for TAVR.

29. Patient refuses blood products.

30. BMI > 50 kg/m2

31. Estimated life expectancy < 24 months.

32. Absolute contraindications or allergy to iodinated contrast that cannot beadequately treated with pre-medication.

33. Immobility or significant cognitive impairment that would prevent completion ofstudy procedure.

34. Currently participating in an investigational drug or another device study.

35. Unsuitable as candidates by the principal investigator or a research associate forother reasons