EFS Study of the Renal Nerve Mapping/Selective Renal Denervation (msRDN) System in the Absence of Antihypertensive Medications: A Prospective, Multicentre, Single-Arm Exploratory Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in daytime ASBP
研究概览
简要总结
This small-scale, proof-of-concept pilot study aims to obtain preliminary evidence of msRDN procedural safety, feasibility, and short-term efficacy in patients with hypertension without medication therapy, to adequately plan an appropriate pivotal study.
详细描述
This is a prospective, multicenter, single-arm, exploratory study enrolling 15 subjects across approximately four sites with a 6-month follow-up period. Subjects are patients with uncontrolled hypertension who receive 1-2 antihypertensive medications and have completed a minimum two-week medication wash-out period prior to enrollment, or patients with uncontrolled hypertension without medication therapy.
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
- •Age ≥ 18 years
- •Documented essential hypertension
- •Resistant or drug-intolerant hypertension, particularly in patients requiring medication reduction
- •Office BP ≥ 140/90 mmHg and < 180/110 mmHg while on a stable regimen of 1-2 antihypertensive medications for ≥ 4 weeks before consent
- •Documented daytime ASBP ≥ 135 mmHg and < 170 mmHg after 2-week washout
- •Able and willing to comply with all study procedures and follow-up visit
排除标准
- •1.Renal artery anatomy on either side, unsuitable for treatment:
- •Main renal artery diameter < 4 mm or > 8 mm
- •Main renal artery length < 25 mm
- •Single functioning kidney
- •Presence of abnormal kidney (or secreting adrenal) tumors
- •Renal artery with aneurysm
- •Pre-existing renal stent or history of renal artery angioplasty
- •Prior renal denervation procedure
- •Renal artery stenosis ≥ 50% 2.Active infection within 7 days of procedure 3.Iliac/femoral artery stenosis precluding msRDN catheter insertion 4.Type I diabetes mellitus 5.eGFR <45 mL/min/1.73 m2 (by Modification of Diet in Renal Disease formula) 6.Any history of cerebrovascular event (e.g. stroke, transient ischemic event, cerebrovascular accident) 7.Any history of severe cardiovascular event (myocardial infarction, CABG, acute heart failure requiring hospitalization (NYHA III-IV) 8.Documented confirmed episode(s) of stable or unstable angina 9.Documented repeat (> 1) hospitalization for hypertensive crisis within the prior 12 months 10.Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea 11.Primary pulmonary hypertension 12.Documented contraindication or allergy to contrast medium not amenable to treatment 13.Limited life expectancy of < 1 year at the discretion of the Investigator 14.Known drug/alcohol dependence or inability to comply with study protocol Pregnant, breastfeeding or intend to become pregnant within 12 months -
研究组 & 干预措施
Mapping/Selective Renal Denervation
Mapping/Selective Renal Denervation
干预措施: The SymPioneer G2 Mapping/Selective Renal Denervation Device and SyMapCath Catheter II (Device)
结局指标
主要结局
Change in daytime ASBP
时间窗: From baseline to 2 months after RDN
mean change in average daytime ASBP from baseline to 2 months post-procedure.
次要结局
- Change in office SBP(From baseline to 1, 2, 3 and 6 months after RDN)
- Change in average 24-hr/Night-time Ambulatory BP(Systolic and Diastolic)(From baseline to 2 months after RDN (for both 24-hr and night-time SBP/DBP); From baseline to 2 months after RDN (for daytime DBP))
- Change in 24-hr Ambulatory BP(From baseline to 6 months after RDN)
- Change in anti-hypertensive Drugs(From baseline to 1, 2, 3 and 6 months after RDN)