A Randomized Trial of Six-Channel RF Ablation System for Renal Denervation in Uncontrolled Hypertension and Chronic Kidney Disease

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Six-channel RF Renal Denervation System
  DSA-guided percutaneous renal sympathetic denervation using a six-channel RF renal denervation system-comprising the six-channel radiofrequency generator (specification model: 25D1G, software release version: SRG-V1) and the ultra-guiding radiofrequency denervation catheter (specification model: 25C6W127F115T)
• Процедура Parallel controln with sham operation(there is no rade and/or generic name,It is a blank control sham operation)
  Sham procedure including femoral artery puncture and selective renal angiography; the six-channel radiofrequency generator is connected to a dummy load and produces activation sounds, but no energy is delivered. Minimum table time before sheath removal is 35 minutes.

Первичные конечные точки

• Change from Baseline in 24-hour Ambulatory Systolic Blood Pressure at Month 6 (ABPM) [Срок оценки: Baseline to Month 6 post-procedure]

Вторичные конечные точки (12)

• Change from Baseline in 24-hour Ambulatory Diastolic Blood Pressure at Month 6 (ABPM) [Срок оценки: Baseline to Month 6 post-procedure]
• Change from Baseline in 24-hour Ambulatory Blood Pressure (including both systolic and diastolic BP) [Срок оценки: Baseline to Months 1, 3, 12, 24, and 36 post-procedure]
• Change from Baseline in Daytime and Nighttime Ambulatory Systolic Blood Pressure (ABPM) [Срок оценки: 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) [Срок оценки: Baseline to Months 1, 3, 6, 12, 24, and 36 post-procedure]
• Percentage of Participants with 24-hour Ambulatory Systolic BP <130 mmHg [Срок оценки: 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) [Срок оценки: Months 1, 3, 6, 12, 24, and 36 post-procedure]
• Responder Rate: ≥5 mmHg Reduction in 24-hour Ambulatory Systolic BP [Срок оценки: Months 1, 3, 6, 12, 24, and 36 post-procedure]
• Change from Baseline in Antihypertensive Medication Use [Срок оценки: 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 Cardiac Function (by Echocardiography) [Срок оценки: Baseline to Months 1, 3, 6, 12, 24, and 36 post-procedure]
• Change from Baseline in Heart Rate (by ECG) [Срок оценки: Baseline to Months 1, 3, 6, 12, 24, and 36 post-procedure]
• Device and Procedure Success [Срок оценки: Intra-procedure (Day 0)]
• Periprocedural major adverse event (MAE) rate [Срок оценки: Baseline to 30 days post-procedure]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Anzhen Hospital, affiliated to Capital Medical University — Пекин

Идентификаторы

NCT: NCT07130955 · MLWY-S20250422

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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