Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation

Inclusion Criteria:

1. Subject who is judged by a Heart Team, including a cardiac surgeon, to beappropriate for transcatheter heart valve intervention therapy, and is deemed to beat intermediate or low risk for open surgical aortic valve replacement (i.e., heartteam estimates risk of surgical mortality < 7% at 30 days, considering the Societyof Thoracic Surgeons (STS) risk score, overall clinical status, and other clinicalco-morbidities unmeasured by the risk calculator). *

2. New York Heart Association (NYHA) Functional Classification of II, III, or IV *

3. Degenerative aortic valve stenosis with echo-derived criteria, defined as: aortic valve area (AVA) of ≤ 1.0 cm2 (or indexed EOA ≤ 0.6 cm2/m2) AND either meangradient ≥ 40 mmHg or peak jet velocity ≥ 4.0 m/s or doppler velocity index (DVI) ≤ 0.25. The echocardiogram supporting the qualifying AVA baseline measurement must beperformed within 90 days prior to informed consent). *

4. Aortic annulus diameter of 19-30 mm and ascending aorta diameter of 26-44 mm for thespecified valve size listed in the IFU, as measured by CT (systolic phase) conductedwithin 12 months prior to informed consent.

Exclusion Criteria:

1. Life expectancy is less than 2 years in the opinion of the Investigator.

2. Evidence of an acute myocardial infarction [defined as ST-segment elevationmyocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) with acute ischemia symptoms and troponin elevation] within 30 days priorto index procedure.

3. Untreated clinically significant coronary artery disease requiringrevascularization.

4. Any percutaneous coronary or peripheral interventional procedure performed within 30days prior (except pacemaker or implantable cardioverter defibrillator (ICD)implant) to index procedure or planned within 30 days following the index procedure.

5. Blood dyscrasias as defined: leukopenia (WBC < 3000 mm3), acute anemia (Hb < 9g/dL), thrombocytopenia (platelet count < 50,000 cells/mm³); history of bleedingdiathesis or coagulopathy

6. Active peptic ulcer or upper GI bleeding within 3 months prior to index procedurethat would preclude anticoagulation

7. Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA) or a transient ischemic attack (TIA)

8. Renal insufficiency (creatinine > 3.0 mg/dL or eGFR < 30 ml/min/1.73m2) and/ or endstage renal disease requiring chronic dialysis

9. Hostile chest or conditions or complications from prior surgery that would make thesubject be considered high surgical risk (i.e., mediastinitis, radiation damage,abnormal chest wall, porcelain aorta, adhesion of aorta or internal mammary arteryto sternum, etc.) *

10. Significant frailty as determined by the heart team (after objective assessment offrailty parameters) that would indicate high or extreme surgical risk *

11. Mixed aortic valve disease (aortic stenosis and aortic regurgitation withpredominant aortic regurgitation 3-4+) *

12. Aortic valve is a congenital unicuspid or congenital bicuspid valve as verified byechocardiography or CT *

13. Severe ventricular dysfunction with LVEF < 30% as measured by resting echocardiogram

14. Pre-existing prosthetic heart valve or other implant (such as prosthetic ring ortranscatheter edge-to-edge repair (TEER) clip) in any valve position * (Note:Subjects with a bioprosthetic aortic valve may be included in the ViV cohort.)

15. Severe circumferential mitral annular calcification (MAC) which is continuous withcalcium in the left ventricular outflow tract (LVOT) *

16. Severe (greater than or equal to 3+) mitral regurgitation or severe mitral stenosiswith pulmonary compromise

17. Minimum access vessel diameter of < 5.0 mm for small FlexNav Delivery System and < 5.5 mm for large FlexNav Delivery System

18. Eccentricity ratio of the annulus < 0.73

• Criterion not applicable for valve-in-valve application