Clinical trial · Interventional
POC for the Treatment of Subjects With Moderate AS Using Valvosoft® Non-Invasive Ultrasound Therapy
Proof of Concept Clinical Investigation for the Treatment of Subjects With Moderate Aortic Valve Stenosis Using Valvosoft® Non-Invasive Ultrasound Therapy
NCT06650839CI-TRIAL-00100327withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): company decision not to start the study
Summary
Brief summary (as posted)
This study is a proof of concept looking at the safety of treating subjects with moderate aortic stenosis using a Non-Invasive Ultrasound Therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Moderate Aortic Valve Stenosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NIUT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment MAS
- description
- Subjects will be treated with Valvosoft, Ultrasound guided Non-Invasive Ultrasound Therapy (NIUT) medical device, to reduce the symptoms caused by moderate aortic stenosis
- interventionNames
- Device: NIUT
Primary outcomes (2)
- measure
- Rate of MACE
- timeFrame
- from baseline to 30 days FU
- description
- Rate of MACE defined as a composite of all-cause mortality, MI, stroke, rehospitalization for heart failure at 30 days.
- measure
- Improvement in leaflet mobility
- timeFrame
- at 6 months FU compared to baseline
- description
- Change in leaflet mobility measured by means of a change in AVA
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.