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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2027-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Moderate Aortic Valve Stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment MAS

Subjects will be treated with Valvosoft, Ultrasound guided Non-Invasive Ultrasound Therapy (NIUT) medical device, to reduce the symptoms caused by moderate aortic stenosis

Group Type EXPERIMENTAL

NIUT

Intervention Type DEVICE

Treatment of moderate aortic stenosis using non-invasive ultrasound therapy delivered by Valvosoft

Interventions

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NIUT

Treatment of moderate aortic stenosis using non-invasive ultrasound therapy delivered by Valvosoft

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No