VALVOSOFT® Pivotal Study

Who can take part

• Subject suffering from severe symptomatic calcific aortic valve stenosis as defined by ESC/EACTS guidelines for the management of valvular heart disease 2021; and
• Subject is not recommended by the local HEART Team for immediate TAVR/SAVR; or
• Subject who refuses TAVR/SAVR, documented by local HEART Team (not allowed in France); and
• Age ≥18 years; and
• Subject willing to provide a written informed consent prior to participating in the study; and
• Subject who can comply with the study follow-up or other study requirements; and
• Subject is eligible for the Valvosoft procedure according to Clinical Review Committee (CRC)

Who cannot take part

• Acute myocardial infarction (MI) within one month prior to enrolment; or
• Stroke or transient ischemic attack (TIA) ≤1 month prior to enrollment; or
• Balloon aortic valvuloplasty (BAV) ≤3 months prior to enrollment; or
• Subject with unstable arrhythmia not controlled by medical treatment; or
• History of heart transplant; or
• Subject requiring other cardiac surgery procedures (bypass graft surgery, mitral valve procedure, tricuspid valve procedure) within one month after Valvosoft procedure; or
• Cardiac imaging evidence of vegetation; or
• Life expectancy < 6 months due to non-cardiac co-morbid conditions; or
• Other medical, psychological, or social condition which, in the opinion of the investigator, precludes the subject from study participation; or
• Left Ventricular Ejection Fraction ≤30%; or
• 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
• Subject with severe aortic regurgitation; or
• Subjects with implanted mechanical valve in any position or bio-prosthetic valve in aortic position; or
• Subject has a chest deformity not allowing optimal placement of Valvosoft Applicator and visualization of the aortic valve; or
• Cardiogenic shock or other hemodynamic instability; or
• Subject with mean AVAI <0,24 cm²/m2; or
• Valve depth not suitable for NIUT (depth >125mm with respect to the Valvosoft imaging probe); or
• Subject who is pregnant, or plan to become pregnant during the 12-months study follow-up period; or
• Subject who is participating in another research study for which the primary endpoint has not been reached; or
• Current endocarditis; or
• Subjects who do not have Social Security and who are under legal restraint; or
• Subjects who cannot read or write or are mentally not or partially capable of giving informed consent