Safety and Feasibility of the Shockwave Medical Transfemoral Aortic Valve Lithotripsy (TAVL) System to treat symptomatic, severe calcified aortic stenosis (TAVL FIM IV)

Shockwave Medical Inc.0 个研究点目标入组 20 人开始时间: 2018年11月27日最近更新: 2018年12月4日

适应症

试验速览

暂无简介。

•1. Age greater than 18 years
•2. Senile degenerative aortic valve stenosis with the following assessed by echocardiogram performed within 60 days of the procedure: a. Mean gradient greater than 40 mmHg or jet velocity greater than 4.0 m/s, and b. An initial aortic valve area (AVA) of less than or equal to 0.8 cm2 or indexed effective orifice area (EOA) less than 0.5 cm2/m2
•3. Symptomatic aortic valve stenosis with NYHA Class greater than Class II
•4. Patient is able and willing to comply with all assessments in the study
•5. Patient or patient’s legal representative has been informed of the nature of the study, agrees to participate and has signed the approved consent form
•6. Patient approved for inclusion by Physician Screening Committee

•1. Bicuspid aortic valve
•2. Rheumatic valve disease
•3. Aortic valve insufficiency greater than 2+
•4. Prior aortic valve surgery or endovascular procedure
•5. Left ventricular ejection fraction (LVEF) less than 30%
•6. Acute myocardial infarction within 30 days
•7. Stroke or transient ischemic attack (TIA) within 12 months
•8. Life expectancy less than one (1) year
•9. High risk for stroke in the judgement of the investigator
•10. History of endocarditis
•11. Active infection
•12. Need for emergency surgery for any reason
•13. Known hypersensitivity or contraindication to anticoagulation, contrast or device components.
•14. Severe vascular disease that would preclude safe access
•15. Planned endovascular or surgical procedures within 30 days of index procedure with the exception of clinically-driven coronary revascularization
•16. Patient is pregnant or nursing
•17. Patient is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.

发起方