WithdrawnNot Applicable

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

Stopped: company decision not to start the study

Serbia0Started 2025-10

Plain-language summary

This study is a proof of concept looking at the safety of treating subjects with moderate aortic stenosis using a Non-Invasive Ultrasound Therapy.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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
✓. 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);
✓. Age ≥18 years;

✕. mPG ≥40 mmHg; or
✕. Severe aortic valve stenosis or other severe valve diseases; or
✕. Subject with severe aortic regurgitation; or
✕. Subjects with implanted mechanical or bioprosthetic valve in aortic position, or mechanical valve in any other positions; or
✕. Heart failure with a NYHA 3 or 4; or
✕. Cardiogenic shock or other hemodynamic instability; or
✕. LVEF ≤50%; or
✕. History of heart transplant; or

Rate of MACE

Timeframe: from baseline to 30 days FU

Improvement in leaflet mobility

Timeframe: at 6 months FU compared to baseline

NCT IDNCT06650839

SponsorCardiawave SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10