VALVOSOFT® Pivotal Study

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.