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

January 5, 2026 updated by: Cardiawave SA

Proof of Concept Clinical Investigation for the Treatment of Subjects With Moderate Aortic Valve Stenosis Using Valvosoft® Non-Invasive Ultrasound Therapy

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
      • Belgrade, Serbia, 11000
        • University Clinical Centre Serbia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Device: NIUT
Treatment of moderate aortic stenosis using non-invasive ultrasound therapy delivered by Valvosoft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of MACE
Time Frame: 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.
from baseline to 30 days FU
Improvement in leaflet mobility
Time Frame: at 6 months FU compared to baseline
Change in leaflet mobility measured by means of a change in AVA
at 6 months FU compared to baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of MACE
Time Frame: at 6 , 12 , 18 , 24 months
Rate of MACE
at 6 , 12 , 18 , 24 months
Rate of all Serious Adverse Events
Time Frame: peri-procedural and at 30 days, 3 , 6 , 12 , 18 , 24 months
Rate of all Serious Adverse Events
peri-procedural and at 30 days, 3 , 6 , 12 , 18 , 24 months
Rate of Stroke
Time Frame: at 30 days, 3 , 6 , 12 , 18 , 24 months
Rate of stroke (disabling and non-disabling; ischemic and hemorrhagic
at 30 days, 3 , 6 , 12 , 18 , 24 months
Change of AS
Time Frame: 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
at 30 days, 3 , 6 , 12 , 18 , 24 months compared to Baseline;
Change in Quality of Life by means of KCCQ
Time Frame: 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.
at 30 days, 3 , 6 , 12 , 18 , 24 months compared to Baseline;
Change in Quality of Life by means of EQ-5D
Time Frame: 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.
at 30 days, 3 , 6 , 12 , 18 , 24 months compared to Baseline;
Change in Exercise capacity
Time Frame: at 30 days, 6 , 12 , 18 , 24 months compared to Baseline;
Improvement in VO2-max measured during Echo Spiro-Ergometry (ESE)
at 30 days, 6 , 12 , 18 , 24 months compared to Baseline;

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiawave SA

Collaborators

Micro Cro
TWrite

Investigators

  • Principal Investigator: Milos Velinovic, MD, PhD, University Clinical Centre Serbia
  • Principal Investigator: Danijela Trifunovic-Zamklar, MD, PhD, University Clinical Centre Serbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

October 14, 2024

First Submitted That Met QC Criteria

October 17, 2024

First Posted (Actual)

October 21, 2024

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CW23-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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