NL-OMON55716已完成不适用
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-Man. - VALVOSOFT® FIM-STUDY
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Subjects suffering from severe symptomatic aortic valve stenosis according
- •to ESC 2017 definition, including subjects with a bicuspid valve.
- •2. Patient is not eligible for TAVR/SAVR according to local Heart Team.
- •3. Age >=18 years.
- •4. Subjects who are willing to provide a written informed consent prior to
- •participating in this clinical investigation.
- •5. Subjects who can comply with the study follow-up or other study requirements.
- •6. Patient is eligible for the Valvosoft procedure according to CRC.
排除标准
- •1. Subjects with any electrical device implanted.
- •2. Subjects with unstable arrhythmia not controlled by medical treatment.
- •3. Subjects with implanted mechanical valve in any position or bio prosthetic
- •valve in aortic position.
- •4. Subjects with complex congenital heart disease.
- •5. Chest deformity.
- •6. Cardiogenic shock.
- •7. History of heart transplant.
- •8. Subjects requiring other cardiac surgery procedures (bypass graft surgery,
- •mitral valve procedure, tricuspid valve procedure) within one month after
- •9. Thrombus in heart.
- •10. Acute myocardial infarction, stroke or transient ischemic attack (TIA)
- •within one month prior to enrolment*.
- •11. Subjects who are pregnant or nursing.
- •12. Subjects who are participating in another research study for which the
- •primary endpoint has not been reached.
研究者
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