High Frequency Guided Renal Artery Denervation for Improving Outcome of Renal Ablation Procedure
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 170
- 试验地点
- 3
- 主要终点
- number of responders to renal denervation procedure
研究概览
简要总结
To increase the number of responders using HFS-guided renal artery denervation (RDN) in patients with resistant and moderate resistant hypertension
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Office-based systolic blood pressure of ≥140/90 mm Hg and <160/100 mm Hg (moderate resistant hypertension) or ≥160/100 mm Hg (severe resistant hypertension), despite treatment with 3 antihypertensive drugs (including a diuretic).
- •A glomerular filtration rate ≥45 mL/min/1⋅73 m2, with modification of diet using a renal disease formula.
排除标准
- •Secondary causes of hypertension
- •Severe renal artery stenosis or dual renal arteries
- •Congestive heart failure
- •Left ventricular ejection fraction <35%
- •Previous renal artery stenting or angioplasty
- •Type 1 diabetes mellitus
研究组 & 干预措施
Group 1 (RDN guided by HFS)
Renal arteries were assessed for suitability of ablation by renal angiography. The real-time 3-dimensional aorta-renal artery maps were reconstructed with the use of navigation system and ablation catheter via femoral artery access. After that high-frequency stimulation (HFS) was used before the initial and after each radiofrequency (RF) delivery within the renal artery. RDN was considered to have been achieved when the sudden increase of blood pressure (> 15 mm Hg from invasive arterial monitoring) was eliminated in response to HFS.
RF ablations of 8-12 watts (impedance drop >10%) were applied discretely from the first distal main renal artery bifurcation all the way back to the ostium. The duration of each RF delivery was 60-120 sec, and up to 6 lesions (separated by > 5 mm) were performed both longitudinally and rotationally within each renal artery.
干预措施: Renal denervation guided by HFS (Device)
Group 2 (RDN as standard procedure)
Renal arteries were assessed for suitability of ablation by renal angiography. The real-time 3-dimensional aorta-renal artery maps were reconstructed with the use of navigation system and ablation catheter via femoral artery access.
RF ablations of 8-12 watts (impedance drop >10%) were applied discretely from the first distal main renal artery bifurcation all the way back to the ostium. The duration of each RF delivery was 60-120 sec, and up to 6 lesions (separated by > 5 mm) were performed both longitudinally and rotationally within each renal artery. High-frequency stimulation (HFS) was performed before and after RDN to just to verify the response of BP
干预措施: Renal denervation as standard procedure (Device)
结局指标
主要结局
number of responders to renal denervation procedure
时间窗: 12 month
次要结局
- complications rate(12 month)
- cross-over rate(12 month)