NCT05235568已完成不适用
Prospective, Single-arm Pivotal Study for the Treatment of Subjects With Severe Symptomatic Calcific Aortic Valve Stenosis Using Valvosoft® Non-Invasive Ultrasound Therapy (NIUT)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 15
- 主要终点
- Safety endpoint
研究概览
简要总结
The objective of the study is to evaluate the safety and performance of a new non-invasive ultrasound therapy (NIUT) with Valvosoft in the treatment of Calified Aortic Stenosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Subject suffering from severe symptomatic calcific aortic valve stenosis as defined by ESC/EACTS guidelines for the management of valvular heart disease 2021; and
- •Subject is not recommended by the local HEART Team for immediate TAVR/SAVR; or
- •Subject who refuses TAVR/SAVR, documented by local HEART Team (not allowed in France); and
- •Age ≥18 years; and
- •Subject willing to provide a written informed consent prior to participating in the study; and
- •Subject who can comply with the study follow-up or other study requirements; and
- •Subject is eligible for the Valvosoft procedure according to Clinical Review Committee (CRC).
排除标准
- •Subject with severe aortic regurgitation; or
- •Subject with unstable arrhythmia not controlled by medical treatment; or
- •Subjects with implanted mechanical valve in any position or bio-prosthetic valve in aortic position; or
- •Subject has a chest deformity not allowing optimal placement of Valvosoft Applicator and visualization of the aortic valve; or
- •Cardiogenic shock or other hemodynamic instability; or
- •Left Ventricular Ejection Fraction ≤30%; or
- •Subject with mean AVAI <0,24 cm²/m2; or
- •History of heart transplant; or
- •Subject requiring other cardiac surgery procedures (bypass graft surgery, mitral valve procedure, tricuspid valve procedure) within one month after Valvosoft procedure; or
- •Cardiac imaging evidence of vegetation; or
- •Acute myocardial infarction (MI) within one month prior to enrolment; or
- •Valve depth not suitable for NIUT (depth >125mm with respect to the Valvosoft imaging probe); or
- •Stroke or transient ischemic attack (TIA) ≤1 month prior to enrollment; or
- •Subject who is pregnant, or plan to become pregnant during the 12-months study follow-up period; or
- •Subject who is participating in another research study for which the primary endpoint has not been reached; or
- •Balloon aortic valvuloplasty (BAV) ≤3 months prior to enrollment; or
- •Current endocarditis; or
- •Leukopenia (WBC <4000 cell/μL), anemia (Hgb <8 g/dL), thrombocytopenia (platelet count <15.000 cell/μL), or history of coagulopathy or hypercoagulable state; or
- •Life expectancy < 6 months due to non-cardiac co-morbid conditions; or
- •Other medical, psychological, or social condition which, in the opinion of the investigator, precludes the subject from study participation; or
- •Subjects who do not have Social Security and who are under legal restraint; or
- •Subjects who cannot read or write or are mentally not or partially capable of giving informed consent.
结局指标
主要结局
Safety endpoint
时间窗: at 30 days post-procedure
Rate of MACE \< 25%
Performance endpoint
时间窗: at 30 days post-procedure
Improvement in clinical status assessed by means of a decrease in NHYA functional class
次要结局
- Rate of MACE(peri-procedureal, and at 3-, 6- and 12 months post procedure)
- All cause mortality(30 days, 3-, 6- and 12-months post procedure)
- Rate of Stroke(30 days, 3-, 6- and 12-months post procedure;)
- AVA change in severity(at 6- and 12 months)
- Improvement of quality of life by Kansas City Cardiomyopathy Questionnaire (KCCQ)(30 days, 6-, and 12-months)
- Change in 6 minutes walk test(30 days, 6- and 12 months)
- AVA change at 30 days(30 days post procedure)
- NYHA improvement(3-, 6- and 12-months)
- Improvement of quality of life by EQ-5D(30 days, 6-, and 12-months)
研究者
研究点 (15)
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