Moderate Aortic Valve StenosisNCT06650839
POC for the Treatment of Subjects With Moderate AS Using Valvosoft® Non-Invasive Ultrasound Therapy
A study testing NIUT in people with Moderate Aortic Valve Stenosis, run by Cardiawave SA at 1 site in Serbia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate Aortic Valve Stenosis
- What is being tested?
- NIUT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSerbia
- Study dates
- Oct 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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);
- Age ≥18 years;
Who cannot join
- mPG ≥40 mmHg; or
- Severe aortic valve stenosis or other severe valve diseases; or
- Subject with severe aortic regurgitation; or
- Subjects with implanted mechanical or bioprosthetic valve in aortic position, or mechanical valve in any other positions; or
- Heart failure with a NYHA 3 or 4; or
- Cardiogenic shock or other hemodynamic instability; or
Show all 13Show fewer
- LVEF ≤50%; or
- History of heart transplant; or
- Subject with a significant kidney disease (eGFR ≤30 mL/min/1.73 m2) or subject is on dialysis; or
- 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
- Cardiac imaging evidence of vegetation; or
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Moderate Aortic Valve Stenosis
- Being tested
- NIUT
- Keywords
- aortic stenosis, moderate, aortic valve, balloon valvuloplasty, TAVR, SAVR, Ultrasound, FUS, PCUT, NIUT
- Medical subject headings
- Aortic Valve Stenosis, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIUTDevice
Treatment of moderate aortic stenosis using non-invasive ultrasound therapy delivered by Valvosoft
| Study group | Role | What they receive |
|---|---|---|
| Treatment MAS | Experimental | Subjects will be treated with Valvosoft, Ultrasound guided Non-Invasive Ultrasound Therapy (NIUT) medical device, to reduce the symptoms caused by moderate aortic stenosis Receives: Device: NIUT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of MACE
Rate of MACE defined as a composite of all-cause mortality, MI, stroke, rehospitalization for heart failure at 30 days.
Measured: from baseline to 30 days FU
Improvement in leaflet mobility
Change in leaflet mobility measured by means of a change in AVA
Measured: at 6 months FU compared to baseline
Secondary outcomes (7)
Rate of MACE
Rate of MACE
Measured: at 6 , 12 , 18 , 24 months
Rate of all Serious Adverse Events
Rate of all Serious Adverse Events
Measured: peri-procedural and at 30 days, 3 , 6 , 12 , 18 , 24 months
Rate of Stroke
Rate of stroke (disabling and non-disabling; ischemic and hemorrhagic
Measured: at 30 days, 3 , 6 , 12 , 18 , 24 months
Change of AS
Change of AS by means of AVA( assessed by an independent echocardiographic CoreLab
Measured: at 30 days, 3 , 6 , 12 , 18 , 24 months compared to Baseline;
Change in Quality of Life by means of KCCQ
Improvement of quality of life by means of ansas City Cardiomyopathy Questionnaire (KCCQ). KCCQ is a 23-item, self-administered questionnaire.
Measured: at 30 days, 3 , 6 , 12 , 18 , 24 months compared to Baseline;
Change in Quality of Life by means of EQ-5D
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.
Measured: at 30 days, 3 , 6 , 12 , 18 , 24 months compared to Baseline;
Change in Exercise capacity
Improvement in VO2-max measured during Echo Spiro-Ergometry (ESE)
Measured: at 30 days, 6 , 12 , 18 , 24 months compared to Baseline;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study startOct 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionDec 2027 (estimated)
Why it stopped: company decision not to start the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiawave SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Micro Cro, TWrite
- Responsible party
- Sponsor
- Investigators
- Milos Velinovic, MD, PhD, Principal investigator, University Clinical Centre SerbiaDanijela Trifunovic-Zamklar, MD, PhD, Principal investigator, University Clinical Centre Serbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650839
- Sponsor's protocol ID
- CW23-02
- Status last verified
- Jan 2026
- First submitted
- 14 Oct 2024
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept Clinical Investigation for the Treatment of Subjects With Moderate Aortic Valve Stenosis Using Valvosoft® Non-Invasive Ultrasound Therapy
- ClinicalTrials.gov ID
- NCT06650839
- Acronym / sponsor ID
- CW23-02
- Conditions
- Moderate Aortic Valve Stenosis
- Keywords
- aortic stenosis, moderate, aortic valve, balloon valvuloplasty, TAVR, SAVR, Ultrasound, FUS
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: company decision not to start the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cardiawave SAIndustry (pharma, biotech, devices)
- Collaborators
- Micro Cro, TWrite
- Study start
- Oct 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment MAS | Experimental | Device: NIUTSubjects will be treated with Valvosoft, Ultrasound guided Non-Invasive Ultrasound Therapy (NIUT) medical device, to reduce the symptoms caused by moderate aortic stenosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
- 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);
- Age ≥18 years;
Key exclusion criteria (13 listed)
- mPG ≥40 mmHg; or
- Severe aortic valve stenosis or other severe valve diseases; or
- Subject with severe aortic regurgitation; or
- Subjects with implanted mechanical or bioprosthetic valve in aortic position, or mechanical valve in any other positions; or
- Heart failure with a NYHA 3 or 4; or
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIUTTreatment of moderate aortic stenosis using non-invasive ultrasound therapy delivered by Valvosoft | Device | Treatment MAS |
Primary outcome
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.
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
7 secondary outcomes
Rate of MACE
Time frame: 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 Stroke
Time frame: 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 in Quality of Life by means of KCCQ
Time frame: 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;
Change in Exercise capacity
Time frame: at 30 days, 6 , 12 , 18 , 24 months compared to Baseline;
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No
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Sparrow App Guided Evaluation (SAGE) Vanguard Trial for Aortic Stenosis in Adults Aged Seventy and Older
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milos Velinovic, MD, PhD principal investigator
University Clinical Centre Serbia
Danijela Trifunovic-Zamklar, MD, PhD principal investigator
University Clinical Centre Serbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIUT in people with Moderate Aortic Valve Stenosis, run by Cardiawave SA at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of MACE (time frame: from baseline to 30 days FU). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.