To Evaluate the Efficacy and Safety of Six-Channel Radiofrequency Ablation System for Renal Denervation in Patients With Uncontrolled Hypertension Combined With Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- Change from Baseline in 24-hour Ambulatory Systolic Blood Pressure at Month 6 (ABPM)
研究概览
简要总结
Prospective, Multi-Center, Randomized, Parallel-Controlled, Uptake clinical trial to evaluate the efficacy and safety of the six-channel radiofrequency（RF) renal denervation system-comprising the six-channel radiofrequency generator (specification model: 25D1G, software release version: SRG-V1) and the disposable ultra-guiding radiofrequency denervation catheter (specification model: 25C6W127F115T)-for renal denervation in patients with uncontrolled hypertension and chronic kidney disease.
详细描述
The six-channel RF renal denervation system, consisting of the six-channel radiofrequency generator (specification model: 25D1G, software release version: SRG-V1) and the disposable ultra-guiding radiofrequency denervation catheter (specification model: 25C6W127F115T), is designed and manufactured by Shanghai Golden Leaf MedTec Co., Ltd (BRATTEA) for renal artery radiofrequency denervation.
This Prospective, Multi-Center, Randomized, parallel-controlled uptake clinical trial aims to evaluate the system's efficacy and safety for renal denervation in patients with uncontrolled hypertension and chronic kidney disease, and to provide clinical evidence supporting the expansion of indications. The trial will be conducted by the Regulations on the Supervision and Administration of Medical Devices, the Measures for the Administration of Medical Device Registration and Filing, the Good Clinical Practice for Medical Devices, and other applicable requirements.
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
- Single (Participant)
盲法说明
The trial will enroll 236 subjects (trial group: control group = 1:1)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18 to 65 years, inclusive, at the time of consent;
- •Hypertensive subjects who have been taking 2 types of standardized antihypertensive drugs continuously and stably for at least 4 weeks, with office systolic blood pressure still ≥150 mmHg and <180 mmHg, and 24-hour ambulatory mean systolic blood pressure (24h SBP) ≥135 mmHg and <170 mmHg; or who have been taking ≥3 types of standardized antihypertensive drugs continuously and stably for at least 4 weeks, with office systolic blood pressure ≥140 mmHg and <180 mmHg, and 24h SBP ≥130 mmHg and <170 mmHg;
- •Estimated glomerular filtration rate (eGFR) ≥20 mL/min/1.73m² and <60 mL/min/1.73m²;
- •The subject or his/her legal representative fully understands the content of the informed consent form for this trial and voluntarily signs the written informed consent form.
排除标准
- •Pregnant or breastfeeding, or planning pregnancy during the study.
- •Renal artery anatomy unsuitable for ablation (e.g., ≥50% stenosis, renal artery aneurysm, malformation, renal artery diameter <3 mm, or treatable segment length <20 mm).
- •Subjects with a solitary kidney, prior renal transplantation, or requiring dialysis.
- •Prior renal artery intervention or prior renal denervation.
- •Other secondary hypertension not related to kidney disease (such as primary aldosteronism, pheochromocytoma/paraganglioma, Cushing's syndrome, thyroid disease, aortic coarctation, monogenic hypertension, renovascular hypertension, etc.).
- •Allergic to contrast agents.
- •Major surgery or trauma within 1 month before enrollment; acute coronary syndrome within 6 months; or planned surgery or cardiovascular interventional therapy within the next 6 months.
- •Orthostatic hypotension.
- •Type 1 diabetes mellitus.
- •Primary pulmonary arterial hypertension.
- •History of bleeding diathesis and haematological disorders or coagulopathy
- •History of thromboembolic event within 6 months.
- •History of stroke or transient ischemic attack (TIA) within 6 months.
- •Severe peripheral arterial disease or unstable abdominal aortic aneurysm.
- •Severe valvular heart disease or anticipated need for surgical valve replacement during the study period.
- •NYHA Class III/IV heart failure at screening or hospitalization for exacerbation of chronic heart failure within the past six months.
- •History of ventricular fibrillation, polymorphic ventricular tachycardia within six months, or prior implantation of an implantable cardioverter-defibrillator (ICD) or pacemaker.
- •Acute kidney injury (AKI) within 4 weeks before enrollment or acute kidney disease ，AKI: ≥50% increase in serum creatinine within 7 days, or absolute increase ≥0.3 mg/dL (≥26.5 μmol/L) within 48 hours, or oliguria (<0.5 mL·kg-¹·h-¹ for ≥6 hours).
- •Severe hepatic dysfunction.
- •Concomitant severe diseases that may interfere with study participation or affect survival, such as malignancy or AIDS.
- •Known drug or alcohol dependence, difficulty understanding the study protocol, inability or unwillingness to comply with follow-up requirements.
- •Current or planned participation in other clinical trials of drugs or medical devices (post-marketing registry studies permitted).
- •Acute or severe systemic infection.
- •Other conditions deemed unsuitable for participation by the investigator.
研究组 & 干预措施
Renal Denervation (RDN)
Participants receive percutaneous renal sympathetic denervation under digital subtraction angiography (DSA) guidance using a six-channel radiofrequency generator(model 25D1G, software release SRG-V1) and ultra-guiding radiofrequency denervation catheter (model 25C6W127F115T) manufactured by Shanghai Golden Leaf MedTec Co., Ltd(BRATTEA). All participants receive a standardized antihypertensive regimen for ≥4 weeks before the procedure and thereafter per protocol. Follow-up visits occur at 7 days or before discharge, and at 1, 3, 6, 12, 24, and 36 months.
Assigned Interventions: Device: Six-channel RF Renal Denervation System; Drug: Standardized Antihypertensive Therapy
干预措施: Six-channel RF Renal Denervation System (Device)
Parallel control with sham operation
Participants undergo a sham procedure: femoral artery puncture and selective renal angiography under DSA guidance are performed. The RF generator is connected to a dummy load, and activation sounds are emitted, but no energy is delivered. Participants remain on the procedure table for at least 35 minutes before sheath removal. Background standardized antihypertensive therapy is provided for ≥4 weeks pre-procedure and continued per protocol. Follow-up visits occur at 7 days or before discharge, and at 1, 3, 6, and 12 months. After completing the 6-month visit, participants may transition to active RDN and then be followed up to 36 months; those declining crossover will continue follow-up at 12，24 and 36 months.
Assigned Interventions: Procedure: Sham operation; Drug: Standardized Antihypertensive Therapy
干预措施: Parallel controln with sham operation(there is no rade and/or generic name,It is a blank control sham operation) (Procedure)
结局指标
主要结局
Change from Baseline in 24-hour Ambulatory Systolic Blood Pressure at Month 6 (ABPM)
时间窗: Baseline to Month 6 post-procedure
24-hour mean systolic BP measured by validated ambulatory BP monitoring; change is Month 6 minus Baseline.
次要结局
- Responder Rate: ≥5 mmHg Reduction in 24-hour Ambulatory Systolic BP(Months 1, 3, 6, 12, 24, and 36 post-procedure)
- Change from Baseline in Heart Rate (by ECG)(Baseline to Months 1, 3, 6, 12, 24, and 36 post-procedure)
- Device and Procedure Success(Intra-procedure (Day 0))
- Change from Baseline in Antihypertensive Medication Use(Baseline to hospital discharge or Day 7 (whichever occurs first), and to Months 1, 3, 6, 12, 24, and 36 post-procedure)
- Change from Baseline in 24-hour Ambulatory Diastolic Blood Pressure at Month 6 (ABPM)(Baseline to Month 6 post-procedure)
- Change from Baseline in 24-hour Ambulatory Blood Pressure (including both systolic and diastolic BP)(Baseline to Months 1, 3, 12, 24, and 36 post-procedure)
- Change from Baseline in Daytime and Nighttime Ambulatory Systolic Blood Pressure (ABPM)(Baseline to Months 1, 3, 6, 12, 24, and 36 post-procedure)
- Change from Baseline in Office Blood Pressure (including both systolic and diastolic BP)(Baseline to Months 1, 3, 6, 12, 24, and 36 post-procedure)
- Percentage of Participants with 24-hour Ambulatory Systolic BP <130 mmHg(Months 1, 3, 6, 12, 24, and 36 post-procedure)
- Percentage of subjects with office systolic BP within the target ranges (<140 mmHg and <130 mmHg)(Months 1, 3, 6, 12, 24, and 36 post-procedure)
- Change from Baseline in Cardiac Function (by Echocardiography)(Baseline to Months 1, 3, 6, 12, 24, and 36 post-procedure)
- Periprocedural major adverse event (MAE) rate(Baseline to 30 days post-procedure)
- Safety event rates(Baseline to Months 36 post-procedure)