Moderate Aortic Valve Stenosis
Conditions
Keywords
aortic stenosis, moderate, aortic valve, balloon valvuloplasty, TAVR, SAVR, Ultrasound, FUS, PCUT, NIUT
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.
Interventions
DEVICENIUT
Treatment of moderate aortic stenosis using non-invasive ultrasound therapy delivered by Valvosoft
Sponsors
Micro Cro
TWrite
Cardiawave SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Rate of Stroke | at 30 days, 3 , 6 , 12 , 18 , 24 months | Rate of stroke (disabling and non-disabling; ischemic and hemorrhagic |
| 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 |
| Rate of MACE | at 6 , 12 , 18 , 24 months | Rate of MACE |
| 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. |
| 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) |
| 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. |
| Rate of all Serious Adverse Events | peri-procedural and at 30 days, 3 , 6 , 12 , 18 , 24 months | Rate of all Serious Adverse Events |
Countries
Serbia
Outcome results
None listed