VALVOSOFT® Pivotal Study

Inclusion Criteria: 1. Subject suffering from severe symptomatic calcific aortic valve stenosis as defined by ESC/EACTS guidelines for the management of valvular heart disease 2021; and 2. Subject is not recommended by the local HEART Team for immediate TAVR/SAVR; or 3. Subject who refuses TAVR/SAVR, documented by local HEART Team (not allowed in France); and 4. Age ≥18 years; and 5. Subject willing to provide a written informed consent prior to participating in the study; and 6. Subject who can comply with the study follow-up or other study requirements; and 7. Subject is eligible for the Valvosoft procedure according to Clinical Review Committee (CRC). Exclusion Criteria: 1. Subject with severe aortic regurgitation; or 2. Subject with unstable arrhythmia not controlled by medical treatment; or 3. Subjects with implanted mechanical valve in any position or bio-prosthetic valve in aortic position; or 4. Subject has a chest deformity not allowing optimal placement of Valvosoft Applicator and visualization of the aortic valve; or 5. Cardiogenic shock or other hemodynamic instability; or 6. Left Ventricular Ejection Fraction ≤30%; or 7. Subject with mean AVAI \<0,24 cm²/m2; or 8. History of heart transplant; or 9. Subject requiring other cardiac surgery procedures (bypass graft surgery, mitral valve procedure, tricuspid valve procedure) within one month after Valvosoft procedure; or 10. Cardiac imaging evidence of vegetation; or 11. Acute myocardial infarction (MI) within one month prior to enrolment; or 12. Valve depth not suitable for NIUT (depth \>125mm with respect to the Valvosoft imaging probe); or 13. Stroke or transient ischemic attack (TIA) ≤1 month prior to enrollment; or 14. Subject who is pregnant, or plan to become pregnant during the 12-months study follow-up period; or 15. Subject who is participating in another research study for which the primary endpoint has not been reached; or 16. Balloon aortic valvuloplasty (BAV) ≤3 months prior to enrollment; or 17. Current endocarditis; or 18. Leukopenia (WBC \<4000 cell/μL), anemia (Hgb \<8 g/dL), thrombocytopenia (platelet count \<15.000 cell/μL), or history of coagulopathy or hypercoagulable state; or 19. Life expectancy \< 6 months due to non-cardiac co-morbid conditions; or 20. Other medical, psychological, or social condition which, in the opinion of the investigator, precludes the subject from study participation; or 21. Subjects who do not have Social Security and who are under legal restraint; or 22. Subjects who cannot read or write or are mentally not or partially capable of giving informed consent.