ACTRN12615001280594招募中不适用
First-in-human study for ultrasound based endovascular carotid body ablation in subjects with treatment-resistant hypertension: a safety and feasibility study.
Cibiem Australia Pty Ltd0 个研究点目标入组 45 人开始时间: 2015年11月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Mean daytime systolic ABPM equal or greater than 135 mmHg during screen-in period
- •Adherent to a stable drug regimen of three (3) or more anti-hypertensive medications of different classes (including one (1) diuretic, unless diuretic intolerance is documented), with no medication changes expected for at least six (6) months post-procedure
- •Willingness and able to comply with follow-up requirements
- •Signed informed consent
排除标准
- •Secondary causes of hypertension
- •Calculated eGFR smaller than 30mL/min/1.73m2
- •History of transient ischemic accident or cerebrovascular accident during six (6) months prior to screening
- •History of acute heart failure, congestive heart failure (NYHA class III-IV), myocardial infarction, unstable angina, coronary bypass or coronary angioplasty during six (6) months prior to screening
- •History of ipsilateral carotid endarterectomy treatment or ipsilateral carotid artery stenting
- •Life expectancy of less than 12 months due to other disease
研究者
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