NL-OMON37812
已完成
不适用
Rapid Renal Sympathetic Denervation for Resistant Hypertension Using the OneShot* Ablation System. - RAPID
Maya Medical0 个研究点目标入组 30 人待定
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- high blood pressure
- 发起方
- Maya Medical
- 入组人数
- 30
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •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
排除标准
- •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
结局指标
主要结局
未指定
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SYMPATHY: Renal sympathetic denervation as a new treatment for therapy resistant hypertension.hypertensiehigh blood pressurehypertension10038430NL-OMON39831niversitair Medisch Centrum Utrecht570