ENVISION Clinical Trial

INTERVENTION: Pivotal Randomized Cohort Navitor Transcatheter Aortic Valve Implantation (TAVI) System, including the following: o Navitor Valve (including Navitor Valve (NVTR‐23/25/27/29) and Navitor Valve with Vision Technology (NVRO‐23/25/27/29/35)) o Navitor Loading System (small, large, and LG+)o FlexNavTM Delivery System (small and large) Valve‐in‐Valve Cohort • Navitor Transcatheter Aortic Valve Implantation (TAVI) System, including the following: o Navitor Valve (including Navitor Valve (NVTR‐23/25/27/29) and Navitor Valve with Vision Technology (NVRO‐23/25/27/29/35)) o Navitor Loading System (small, large, and LG+) o FlexNavTM Delivery System (small and large) CONDITION: ; Aortic stenosis narrowing of the heart’s main valve 10046973 PRIMARY OUTCOME: Primary Endpoint; The primary endpoint is a composite of all‐cause mortality or all stroke at 12 months post‐procedure per the VARC‐3 definitions.; ; Descriptive Endpoints; The rate of the following key outcomes will be assessed as descriptive endpoints for the clinical investigation:; 1. Non‐hierarchical composite of all‐cause mortality or all stroke at 30 days; 2. Non‐hierarchical composite of all‐cause mortality, fatal stroke/stroke with disability, type 3/type 4 bleeding, stage 3/stage 4 acute kidney injury, major vascular complications, or major access‐related non‐vascular complications at 30 days; 3. Non‐hierarchical composite of all‐cause mortality or fatal stroke/stroke with disability at 12 months; 4. Technical success (at exit from procedure room) defined as:; • Freedom from mortality; • Successful access, delivery of the device, and retrieval of the delivery system; • Correct positioning of a single prosthetic heart valve into the proper anatomical location; • Freedom from surgery or intervention related to the deviceB or to a major vascular or access‐related, or cardiac structural complication; 5. Device success (at 30 days) defined as:; • Technical success; • Freedom from mortality; • Freedom from surgery or intervention related to the device or to a major vascular or access‐related or cardiac structural complication; • Intended performance of the valve (mean gradient < 20 mmHg, peak velocity < 3 m/sec, Doppler velocity index = 0.25, and less than moderate aortic regurgitation); 6. Mortality (all‐cause, cardiovascular, and valve‐related) at 30 days, 12 months, and annually through 5 years (ViV cohort) or 10 years (pivotal randomized cohort).; 7. Stroke (All stroke, fatal stroke, stroke with disability, and stroke without disability; ischemic vs. hemorrhagic) at 30 days, 12 months, and annually through 5 years (ViV cohort) or 10 years (pivotal randomized cohort).; 8. Transient ischemic attack (TIA) at 30 days and 12 months; 9. Overt bleeding (type 4, type 3, and type 2) at 30 days and 12 months; 10. Major vascular complications at 30 days and 12 months; 11. Major access‐related non‐vascular complications at 30 days and 12 months; 12. Major cardiac structural complications at 30 days and 12 months; 13. Acute kidney injury (stage 4, stage 3, and stage 2) at 30 days and 12 months; 14. Permanent pacemaker insertion at 30 days and 12 months; 15. Myocardial infarction at 30 days and 12 months; 16. Coronary obstruction requiring intervention at 30 days and 12 months; 17. Changes in New York Heart Association (NYHA) functional class at 30 days and 12 months; 18. Changes in health‐related quality of life as evaluated by the Kansas City Cardiomyopathy Questionnaire (KCCQ‐12) at 30 days and 12 months; 19. Hospitalization (or Rehospitalization) (procedure‐related or valve‐related hospitalization, and other cardiovascular hospitalization) at 30 days, 12 months, and annually through 5 years (ViV cohort) or 10 years (pivotal randomized cohort).; 20. Paravalvular leak (none/trace, mild, moderate, or severe) at discharge, 30 days, 12 months, and annually (when echocardiogram collected) through 5 years (ViV cohort) or 10 years (pivotal randomized cohort); 21. Changes in echocardiographic parameters (e.g., mean effective orifice area, mean transvalvular gradient) from baseline to follow‐up at 30 days, 12 months, and annually (when echocardiogram collected) through 5 years (ViV cohort) or 10 years (pivotal randomized cohort); 22. Prosthesis‐patient mismatch at 30 days; 23. Aortic valve reintervention at 30 days, 12 months, and annually through 5 years (ViV cohort) or 10 years (pivotal randomized cohort); 24. Prosthetic valve endocarditis at 12 months and annually through 5 years (ViV cohort) or 10 years (pivotal randomized cohort); 25. Structural valve deterioration at 12 months and annually (when echocardiogram collected) through 5 years (ViV cohort) or 10 years (pivotal randomized cohort); 26. Non‐structural valve dysfunction at 12 months and annually (when echocardiogram collected) through 5 years (ViV cohort) or 10 years (pivotal randomized cohort); 27. Clinically significant prosthetic valve thrombosis at 12 months and annually through 5 years (ViV cohort) or 10 years (pivotal randomized cohort) SECONDARY OUTCOME: N/A INCLUSION CRITERIA: 1. New York Heart Association (NYHA) Functional Classification of II, III, or IV 2. Subject is of legal age for consent in the host country. 3. Subject has been informed of the nature of the trial, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) or Research Ethics Board (REB) of the respective clinical site. 4. Able and willing to return for required follow‐up visits and assessments. 5. 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) or either mean gradient = 40 mmHg or peak jet velocity = 4.0 m/s or doppler velocity inde X(DVI) = 0.25. The echocardiogram supporting the qualifying AVA baseline measurement must be performed within 6 months prior to informed consent. 6. Aortic annulus diameter of 19‐30 mm and ascending aorta diameter of 26‐44 mm for the specified