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

Launched by CARDIAWAVE SA · Oct 17, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for patients with moderate aortic valve stenosis, a condition where the heart's aortic valve narrows, making it harder for the heart to pump blood. The study will use a technique called Non-Invasive Ultrasound Therapy, which means it will not require surgery or any invasive procedures. The main goal is to see if this treatment is safe and can help improve the condition.

To be eligible for the trial, participants must be at least 18 years old and have specific measurements related to their heart function, such as a certain size of the aortic valve and pressure readings. However, individuals with more severe heart issues, certain types of heart valve replacements, or other serious health problems won't be able to participate. If someone joins the study, they can expect to receive careful monitoring and support throughout the process. It's important to note that the trial is not yet recruiting participants, so it's not open for enrollment right now.

Gender

ALL

Eligibility criteria

• 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.