NCT06235554尚未招募不适用
Feasibility Study Evaluating the Safety and Efficacy of the Renal Stimulation by Direct Wire Pacing, During Renal Denervation Procedure.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Ceric Sàrl
- 入组人数
- 10
- 主要终点
- prevalence of occurrence of adverse events
研究概览
简要总结
The goal of this feasibility study is to evaluate the safety and efficacy of the Renal Stimulation (RNS) by Direct Wire Pacing, during Renal Denervation (RDN) procedure in patient candidate for renal denervation with the ParadiseTM System. The main questions it aims to answer are:
- Is the RNS before RDN a straightforward method, allowing quantification of the renal sympathetic traffic?
- Does the RNS increase blood pressure (SBP), and is this increase significantly blunted after RDN?
- Does the 3-month 24h SBP decrease correlated with the RNS-induced SBP change before RDN?
- Can the difference between RNS-induced SBP rise before and after RDN be used as a procedural endpoint for RDN? Participants will be asked for their agreement to conduct an RNS before and after the RDN. No additional experimental procedure will be added to the standard of care.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient willing and able to comply with the protocol and has provided written informed consent.
- •Patient candidate for renal denervation with the ParadiseTM System based on physician's assessment.
- •Patients affiliated to a social security system
排除标准
- •Patients who meet any of the contraindications listed in the Instructions for Use of ParadiseTM Ultrasound Renal Denervation System will be excluded:
- •Renal arteries diameter < 3 mm and > 8 mm
- •Patient with relevant renal artery disease (% diameter stenosis > 30%, aneurysm or fibromuscular disease)
- •Stented renal artery
- •Iliac/femoral artery stenosis precluding insertion of the ParadiseTM catheter
- •Known allergy to contrast medium
- •Patient with known secondary cause of hypertension
- •Patient with contraindication to chronic anticoagulation therapy or heparin
- •Patient with Type 1 diabetes mellitus
- •Patient with more than one accessory renal artery
- •Woman currently pregnant or breastfeeding
- •Patient with other concomitant conditions that may adversely affect the patient or the study outcome
- •Patient with mental or physical inability to participate in the study
- •Patient under judicial protection, tutorship, or curatorship
结局指标
主要结局
prevalence of occurrence of adverse events
时间窗: Three month after procedure
safety of the renal nerves stimulation performed by Direct Wire Pacing technique during renal denervation procedure
efficacy on Systolic Blood Pressure change to be measured with a blood pressure monitor
时间窗: Three month after procedure
efficacy of the renal nerves stimulation performed by Direct Wire Pacing technique during renal denervation procedure
次要结局
- Impact on Systolic Blood Pressure(Three month after procedure)
- Systolic Blood Pressure as response prediction tool(Three month after procedure)
- Systolic Blood Pressure variation as response prediction tool(Three month after procedure)
研究者
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