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

Not Applicable

Not yet recruiting

• Conditions: Moderate Aortic Valve Stenosis

• Registration Number: NCT06650839
• Lead Sponsor: Cardiawave SA

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.

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 Timeline

• Study First Submitted: 2024-10-14
• Study First Submitted QC: 2024-10-17
• Study First Posted: 2024-10-21
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12
• Study Start: 2025-07-15
• Primary Completion: 2026-07-15
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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

13. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Rate of MACE	from baseline to 30 days FU	Rate of MACE defined as a composite of all-cause mortality, MI, stroke, rehospitalization for heart failure at 30 days.
Improvement in leaflet mobility	at 6 months FU compared to baseline	Change in leaflet mobility measured by means of a change in AVA

Secondary Outcome Measures

Name	Time	Method
Rate of all Serious Adverse Events	peri-procedural and at 30 days, 3 , 6 , 12 , 18 , 24 months	Rate of all Serious Adverse Events
Rate of Stroke	at 30 days, 3 , 6 , 12 , 18 , 24 months	Rate of stroke (disabling and non-disabling; ischemic and hemorrhagic
Change in Quality of Life by means of KCCQ	at 30 days, 3 , 6 , 12 , 18 , 24 months compared to Baseline;	Improvement of quality of life by means of ansas City Cardiomyopathy Questionnaire (KCCQ). KCCQ is a 23-item, self-administered questionnaire.
Change in Exercise capacity	at 30 days, 6 , 12 , 18 , 24 months compared to Baseline;	Improvement in VO2-max measured during Echo Spiro-Ergometry (ESE)
Rate of MACE	at 6 , 12 , 18 , 24 months	Rate of MACE
Change of AS	at 30 days, 3 , 6 , 12 , 18 , 24 months compared to Baseline;	Change of AS by means of AVA( assessed by an independent echocardiographic CoreLab
Change in Quality of Life by means of EQ-5D	at 30 days, 3 , 6 , 12 , 18 , 24 months compared to Baseline;	Improvement of quality of life by means of EQ-5D. The EQ-5D descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

Trial Locations

Locations (1)

University Clinical Centre Serbia; 🇷🇸 Belgrade, Serbia