POC for the Treatment of Subjects With Moderate AS Using Valvosoft® Non-Invasive Ultrasound Therapy

Inclusion Criteria: 1. Aortic Valve Area (AVA) ≥1.0 cm2 ≤ 1.5 cm2 and either mean aortic Pressure Gradient (mPG) of \>25 - \< 40 mmHg or maximum velocity (Vmax) ≥3 ≤4 m/sec in normal flow conditions; or 2. Normal-flow, low-gradient aortic stenosis (AS) with preserved ejection fraction (mean aortic Pressure Gradient (mPG) \<40 mmHg, Aortic Valve Area (AVA) ≥0.8 ≤1.0 cm2, Left Ventricular Ejection Fraction (LVEF) ≥50%, Stroke Volume Index (SVi) \>35 mL/m2); 3. Age ≥18 years; Exclusion Criteria: 1. mPG ≥40 mmHg; or 2. Severe aortic valve stenosis or other severe valve diseases; or 3. Subject with severe aortic regurgitation; or 4. Subjects with implanted mechanical or bioprosthetic valve in aortic position, or mechanical valve in any other positions; or 5. Heart failure with a NYHA 3 or 4; or 6. Cardiogenic shock or other hemodynamic instability; or 7. LVEF ≤50%; or 8. History of heart transplant; or 9. Subject with a significant kidney disease (eGFR ≤30 mL/min/1.73 m2) or subject is on dialysis; or 10. Subject with uncontrolled hypertension defined as systolic Blood Pressure (BP) ≥160 mmHg and/or a diastolic BP ≥100 mmHg (mean of 3 measurements for both assessments); or 11. Cardiac imaging evidence of vegetation; or 12. Current endocarditis; or 13 Subject has a documented history of cardiac amyloidosis; or 14\. Acute Myocardial Infarction (MI) ≤1 month prior to enrolment; or 15. Stroke or Transient Ischemic attack (TIA) ≤1 month prior to enrollment; or 16. Balloon Aortic Valvuloplasty (BAV) ≤3 months prior to enrollment; or 17. Leukopenia (WBC \<4000 cell/μL), anemia (Hgb \< 8 g/dL), thrombocytopenia (platelet count \<50.000 cell/μL), or history of coagulopathy or hypercoagulable state.