Proof of Concept Clinical Investigation for the Treatment of Subjects With Moderate Aortic Valve Stenosis Using Valvosoft® Non-Invasive Ultrasound Therapy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Rate of MACE
研究概览
简要总结
This study is a proof of concept looking at the safety of treating subjects with moderate aortic stenosis using a Non-Invasive Ultrasound Therapy.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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
- •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
- •Stroke or Transient Ischemic attack (TIA) ≤1 month prior to enrollment; or
- •Balloon Aortic Valvuloplasty (BAV) ≤3 months prior to enrollment; or
- •Leukopenia (WBC <4000 cell/μL), anemia (Hgb < 8 g/dL), thrombocytopenia (platelet count <50.000 cell/μL), or history of coagulopathy or hypercoagulable state.
研究组 & 干预措施
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
结局指标
主要结局
Rate of MACE
时间窗: 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
时间窗: at 6 months FU compared to baseline
Change in leaflet mobility measured by means of a change in AVA
次要结局
- Rate of all Serious Adverse Events(peri-procedural and at 30 days, 3 , 6 , 12 , 18 , 24 months)
- Rate of Stroke(at 30 days, 3 , 6 , 12 , 18 , 24 months)
- Change in Quality of Life by means of KCCQ(at 30 days, 3 , 6 , 12 , 18 , 24 months compared to Baseline;)
- Rate of MACE(at 6 , 12 , 18 , 24 months)
- Change of AS(at 30 days, 3 , 6 , 12 , 18 , 24 months compared to Baseline;)
- Change in Quality of Life by means of EQ-5D(at 30 days, 3 , 6 , 12 , 18 , 24 months compared to Baseline;)
- Change in Exercise capacity(at 30 days, 6 , 12 , 18 , 24 months compared to Baseline;)