Prospective, Controlled, Single-arm Clinical Investigation for the Treatment of Subjects With Severe Symptomatic Aortic Valve Stenosis Using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-Human
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Safety: Rate of procedure related mortality
研究概览
简要总结
This is a prospective, controlled, single-arm clinical investigation for the treatment of subjects with severe symptomatic aortic valve stenosis using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-Human
详细描述
CARDIAWAVE has developed a new non-invasive, real-time image-guided, therapeutic approach to treat patients suffering from Calcified Aortic Stenosis. CARDIAWAVE's Valvosoft device is a new ultrasound therapy based on a disruptive technology involving delivering an extremely precise and focused ultrasound beam to perform a reparative effect on the aortic valve leaflets, softening the valve's tissues, restoring leaflet mobility, and therefore improving the overall clinical status related to the aortic valve stenosis. In this study, a brai-MRI is performed before the procedure and 24-72 hours after the procedure to detect cerebrovascular events.This is a FIM 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
- •Subjects suffering from severe symptomatic aortic valve stenosis according to ESC 2017 definition, including subjects with a bicuspid valve.
- •Patient is not eligible for TAVR/SAVR according to local Heart Team.
- •Age ≥18 years.
- •Subjects who are willing to provide a written informed consent prior to participating in the study.
- •Subjects who can comply with the study follow up or other study requirements.
- •Patient is eligible for the Valvosoft procedure according to CRC.
排除标准
- •Subjects with any electrical device implanted.
- •Subjects with unstable arrhythmia not controlled by medical treatment.
- •Subjects with implanted mechanical valve in any position or bio prosthetic valve in aortic position.
- •Subjects with complex congenital heart disease.
- •Chest deformity.
- •Cardiogenic shock.
- •History of heart transplant.
- •Subjects requiring other cardiac surgery procedures (bypass graft surgery, mitral valve procedure, tricuspid valve procedure) within one month after treatment.
- •Thrombus in heart.
- •Acute myocardial infarction (MI), stroke or transient ischemic attack (TIA) within one month prior to enrolment*.
- •Subjects who are pregnant or nursing.
- •Subjects who are participating in another research study for which the primary endpoint has not been reached.
结局指标
主要结局
Safety: Rate of procedure related mortality
时间窗: Up to 30 days
Rate of procedure related mortality at 30 days
Device performance to modify valve structure as measured by echocardiography
时间窗: Immediately after the procedure
Ability to modify the Left Ventricular Ejection Fraction (%)
次要结局
- Long term maintenance of improvement of Aortic Valve area and mean Pressure Gradient(At 1, 3, 6,1 2 and 24 months)
- Adverse events(Up to 2 years)
- All-cause mortality(Up to two years)
- Change of severity of heart failure(At 1, 3,6,12 and 24 months)
- Rate of stroke(Up to two years)
- Major Adverse Events(Up to 2 years)
- User Handeling(Immediately after the procedure)
- quality of life measured through Kansas City Cardiomyopathy Questionnaire(at 1, 3, 6, 12 and 24 months)