POC for the Treatment of Subjects With Moderate AS Using Valvosoft® Non-Invasive Ultrasound Therapy
Megadott ok: company decision not to start the study
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A vizsgálat adatai
- Ki végzi
- Cardiawave SA
- Azonosító
- NCT06650839
- A regiszteradat frissítve
- 2026. január 7.
- Eredeti leírás
This study is a proof of concept looking at the safety of treating subjects with moderate aortic stenosis using a Non-Invasive Ultrasound Therapy.A teljes eredeti leírásKevesebb
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.
Bevonási feltételek: 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.
Kizáró feltételek: Severe aortic valve stenosis or other severe valve diseases; or; Heart failure with a NYHA 3 or 4; or; History of heart transplant; 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; LVEF ≤50%; or; Subject with a significant kidney disease (eGFR ≤30 mL/min/1.73 m2) or subject is on dialysis; or; 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; mPG ≥40 mmHg; 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; Cardiogenic shock or other hemodynamic instability; or.