NCT02777216已完成不适用
ConfidenHTTM System Safety and Performance of Diagnostic Electrical Mapping of Renal Nerves in Hypertensive Patients and/or Potential Candidates for a Renal Sympathetic Denervation (RDN) Procedure
BlueWind Medical3 个研究点 分布在 2 个国家目标入组 20 人开始时间: 2016年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- The incidence of serious adverse events (system and/or procedure related events)
研究概览
简要总结
To evaluate the safety and performance of the ConfidenHT System
详细描述
To evaluate the safety and performance of the ConfidenHT System for diagnostic mapping of renal nerves; functional distribution of renal nerves and the effect of renal nerve stimulation on the blood pressure
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent.
- •Age >18 years and <
- •Hypertensive patients planned to undergo elective cardiac catheterization
- •Potential candidates for renal sympathetic denervation
- •Main renal artery with diameter ≥ 4.0mm.
- •Glomerular Filtration Rate (GFR) >45 mL/min
- •A patient who is mentally competent with the ability to understand and comply with the requirements of the study.
- •The patient agrees to attend all follow-up evaluations and is willing to complete required exams and tests.
- •Female patients with childbearing potential must agree:
- •to use a valid method of contraception (oral contraceptives, intrauterine device, subcutaneous contraceptive implant, vaginal ring)
- •to perform a pregnancy test
排除标准
- •Previous participation in another study with any investigational drug or device within the past 30 days.
- •Relevant renal artery disease (% diameter stenosis>30%, aneurysm or fibromuscular dysplasia).
- •Known secondary causes of hypertension.
- •The patient has a life expectancy ≤ 12 months.
- •The patient has undergone prior renal denervation, renal stenting, and/or abdominal aortic stent grafts.
- •The patient has chronic oxygen use other than nocturnal support for sleep apnea.
- •The patient has type I diabetes mellitus.
- •The patient has had a previous organ transplant or is awaiting a renal transplant.
- •Active implantable medical device (e.g. ICD or CRT-D; neuromodulator/spinal stimulator; baroreflex stimulator).
- •The patient has triple ipsilateral artery ostia.
- •Moderate to severe valvular heart disease.
- •The patient has other concomitant conditions that may adversely affect the patient or the study outcome.
- •Female who is pregnant, nursing or planning to become pregnant.
- •Documented contraindication or allergy to contrast medium not amenable to treatment.
研究组 & 干预措施
ConfidenHT system
Experimental
ConfidenHT system
干预措施: ConfidenHT system (Device)
结局指标
主要结局
The incidence of serious adverse events (system and/or procedure related events)
时间窗: 3 months
The incidence of serious adverse events (system and/or procedure related events)
次要结局
未报告次要终点
研究者
研究点 (3)
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