Rapid Renal Sympathetic Denervation for Resistant Hypertension Using the OneShot* Ablation System. - RAPID

Maya Medical0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•1. Systolic blood pressure >= 160 mmHg despite treatment with a regimen of 3 or more anti-hypertensive medications taken at optimal dose amounts including a diuretic and that has been stable for two weeks prior to screening.
•2. Age 18-85 years
•3. Able to provide informed consent and comply with follow-up visits

•1. Diameter of left or right renal artery less then 4mm or greater then 7mm.
•2. Length of treatable segment of renal artery less than 20mm.
•3. Renal arterial abnormalities including severe renal artery stenosis, previous renal stenting or angioplasty.
•4. End-stage renal disease requiring dialysis or renal transplant
•5. eGFR < 45 mL/min per 1.73 m2
•6. Type 1 diabetes mellitus
•7. Myocardial infarction, unstable angina, or cerebrovascular events within 6 months prior to screening
•8. Severe valvular heart disease for which reduction of blood pressure would be considered hazardous
•9. Bleeding disorder or refusing blood transfusions
•10. Pregnancy or breast feeding
•11. Peripheral vascular disease precluding catheter insertion
•12. Any serious medical condition, which in the opinion of the investigator, may adversely affect the safety or effectiveness of the participant or the study
•13. Current enrollment in another investigational drug or device

发起方

Maya Medical