NL-OMON53861招募中不适用
Prospective, Single-arm Pivotal Study for the Treatment of Subjects with Severe Symptomatic Calcific Aortic Valve Stenosis Using Valvosoft® Non-Invasive Ultrasound Therapy (NIUT) - Valvosoft Pivotal Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •A subject must meet following criteria to be enrolled in the investigation:
- •1. Subject suffering from severe symptomatic calcific aortic valve stenosis; and
- •2. Subject is not recommended by the local Heart Team for immediate TAVR/SAVR;
- •3. Subject who refuses TAVR/SAVR, documented by local Heart Team; and
- •4. Age >=18 years; and
- •5. Subject willing to provide a written informed consent prior to participating
- •in the study; and
- •6. Subject who can comply with the study follow-up or other study requirements;
- •7. Subject is eligible for the Valvosoft procedure according to Clinical Review
- •Committee (CRC)
排除标准
- •A subject must not meet any of the following criteria to be enrolled in the
- •investigation: 1. Subject with severe aortic regurgitation; or 2. Subject with
- •unstable arrhythmia not controlled by medical treatment; or 3. Subjects with
- •implanted mechanical valve in any position or bio-prosthetic valve in aortic
- •position; or 4. Subject has a chest deformity not allowing optimal placement of
- •the applicator and visualization of the aortic valve; or 5. Cardiogenic shock
- •or other hemodynamic instability; or 6. Left Ventricular Ejection Fraction
- •<=30%; or 7. Subject with mean AVAI <0,24 cm²/m2; or 8. History of heart
- •transplant; or 9. Subject requiring other cardiac surgery procedures (bypass
- •graft surgery, mitral valve procedure, tricuspid valve procedure) within one
- •month after Valvosoft procedure; or 10. Cardiac imaging evidence of vegetation,
- •or 11. Acute myocardial infarction (MI) within one month prior to enrolment; or
- •12. Valve depth not suitable for NIUT (depth >125mm with respect to the
- •Valvosoft imaging probe). 13. Stroke or transient ischemic attack (TIA) <=1
- •month prior to enrollment; or 14. Subject who is pregnant, or plan to become
- •pregnant during the 12*months study follow*up period; or 15. Subject who is
- •participating in another research study for which the primary endpoint has not
- •been reached; or 16. Balloon aortic valvuloplasty (BAV) <=3 months prior to
- •enrollment; or 17. Current endocarditis; or 18. 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 19. Life expectancy <12
- •months due to non-cardiac co-morbid conditions; or 20. Other medical,
- •psychological, or social condition which, in the opinion of the investigator,
- •precludes the subject from study participation. 21. Subjects who do not have
- •Social Security and who are under legal restraint 22. Subjects who cannot read
- •or write or are mentally not or partially capable of giving informed consent.
研究者
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