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NCT06650839 | NOT YET RECRUITING | Moderate Aortic Valve Stenosis

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

Cardiawave was

Brief 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.

Condition or disease

Moderate Aortic Valve Stenosis

Intervention/treatment

NIUT

Phase

NA

Detailed Description:

Valvosoft, Ultrasound guided Non-Invasive Ultrasound Therapy (NIUT) medical device, delivers focused and controlled, short ultrasound pulses (\<20μsec), directed trans-thoracically at a high acoustic intensity (measured in watts per square centimeter (W/cm2), to produce non-thermal mechanical tissue softening of the targeted calcified aortic valve. Echocardiographic live imaging enables to follow valve movements in real-time and thus target the therapeutic ultrasound on the calcified valve with great precision. This is first in human or proof of concept study.

Study Type : INTERVENTIONAL
Estimated Enrollment : 10 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Proof of Concept Clinical Investigation for the Treatment of Subjects with Moderate Aortic Valve Stenosis Using Valvosoft® Non-Invasive Ultrasound Therapy
Actual Study Start Date : 2025-07-15
Estimated Primary Completion Date : 2026-07-15
Estimated Study Completion Date : 2027-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
POC for the Treatment of Subjects with Moderate AS Using Valvosoft® Non-Invasive Ultrasound Therapy

Location Details

NCT06650839

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Serbia,

University Clinical Centre Serbia

Belgrade, Serbia, 11000