Rapid Renal Sympathetic Denervation for Resistant Hypertension Using the OneShot™ Ablation System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 14
- 主要终点
- Acute Procedural Safety
研究概览
简要总结
The Covidien OneShot™ ablation system use is to deliver low-level radio frequency (RF) energy through the wall of the renal artery to denervate the human kidney.
详细描述
Unique to the OneShot™ ablation system is the ability to deliver the desired helical treatment pattern for optimal Renal Denervation (RDN) with a single balloon based-treatment, eliminating user variance inherent in the currently available point-by-point approach. In addition, technological improvements have been incorporated. The OneShot™ RF generator has a touchscreen, user friendly interface; catheter advancement is made safer with the use of a guidewire; two radiopaque markers on the catheter enable more precise device positioning; and the irrigated catheter tip reduces the risk of overheating and clot formation during RF delivery. By offering a more reliable single treatment approach, coupled with enhanced ease-of use and reduced procedure times, this technology has the potential to significantly expand clinical adoption of catheter-based renal sympathetic denervation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systolic blood pressure ≥ 160 mmHg despite treatment with a regimen of 3 or more anti-hypertensive medications that includes a diuretic and that has been stable for 2 weeks prior to screening.
- •Age 18-85 years.
- •Able to provide informed consent and comply with follow-up visits.
排除标准
- •Diameter of left or right renal artery less than 4 mm or greater than 7mm.
- •Length of target segment of left or right renal artery less than 20mm.
- •Other renal arterial abnormalities including severe renal artery stenosis, previous renal stenting or angioplasty.
- •End-stage renal disease requiring dialysis or renal transplant.
- •estimated Glomerular Filtration Rate < 45 mL/min per 1.73 m
- •Type 1 diabetes mellitus.
- •Myocardial infarction, unstable angina, or cerebrovascular events within 6 months prior to screening.
- •Severe valvular heart disease for which reduction of blood pressure would be considered hazardous.
- •Bleeding disorder or refusing blood transfusions.
- •Pregnancy or breast feeding.
- •Peripheral vascular disease precluding catheter insertion.
- •Any serious medical condition, which in the opinion of the investigator, may adversely affect the safety or effectiveness of the participant or the study.
- •Current enrollment in another investigational drug or device Study.
研究组 & 干预措施
Rapid Renal Denervation
干预措施: Covidien OneShot™ System (Device)
结局指标
主要结局
Acute Procedural Safety
时间窗: One Week
Acute Procedural Safety, defined as the overall rate of Serious Adverse Events (SAE's) and adverse device effects at discharge: * SAE's related to groin and vascular access complications, and * SAE's related to renal artery injury.
次要结局
- Chronic Procedural Safety(6 months)
- Renal Denervation Procedure Effectiveness(From baseline to 6 months)