An interventional study of NIUT in Moderate Aortic Valve Stenosis, sponsored by Cardiawave SA. Withdrawn at 1 site in Serbia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-07.
Sponsored by Cardiawave SA · Not applicable, Interventional, and Treatment
This study is a proof of concept looking at the safety of treating subjects with moderate aortic stenosis using a Non-Invasive Ultrasound Therapy.
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.
985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.
Browse Aortic Valve Stenosis studies →Cardiawave SA is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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
Rate of MACE
Rate of MACE defined as a composite of all-cause mortality, MI, stroke, rehospitalization for heart failure at 30 days.
Time frame: from baseline to 30 days FU
Improvement in leaflet mobility
Change in leaflet mobility measured by means of a change in AVA
Time frame: at 6 months FU compared to baseline
Rate of MACE
Rate of MACE
Time frame: at 6 , 12 , 18 , 24 months
Rate of all Serious Adverse Events
Rate of all Serious Adverse Events
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: at 30 days, 6 , 12 , 18 , 24 months compared to Baseline;
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Cardiawave SA