Safety and Efficacy of Renal Denervation for Untreated Grade I Hypertension: a Pilot Study

Официальное название

Safety and Efficacy of Six-Channel Radiofrequency Ablation System for Renal Denervation in Patients With Untreated Grade I Hypertension: a Pilot Study

Обзор

Prospective, Multi-Center, Randomized, shame-Controlled, Uptake clinical trial to evaluate the efficacy and safety of the six-channel radio-frequency（RF) renal denervation system-comprising the six-channel RF generator (specification model: 25D1G, software release version: SRG-V1) and the disposable ultra-guiding RF denervation catheter (specification model: 25C6W127F115T)-for renal denervation in patients with grade I hypertension and without taking antihypertensive medicines.

Подробное описание

The six-channel RF renal denervation system, consisting of the six-channel RF generator (specification model: 25D1G, software release version: SRG-V1) and the disposable ultra-guiding RF denervation catheter (specification model: 25C6W127F115T), is designed and manufactured by Shanghai Golden Leaf MedTec Co., Ltd (BRATTEA) for renal artery RF denervation.

This Prospective, Multi-Center, Randomized, shame-controlled uptake clinical trial aims to evaluate the system's efficacy and safety for renal denervation in patients with grade I hypertension and without taking antihypertensive medicines, 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 in 24-h ambulatory BP at 3 months post-procedure compared between the 2 groups. [Срок оценки: 3 months]

Вторичные конечные точки (5)

• Change from Baseline in Daytime and Nighttime Ambulatory Systolic /diastolic Blood Pressure (ABPM) [Срок оценки: Baseline to 3 Months]
• Percentage of Participants with 24-hour Ambulatory BP <130 /80 mmHg [Срок оценки: Months 3 post-procedure]
• Change from Baseline in Office Blood Pressure (including both systolic and diastolic BP) [Срок оценки: Baseline to Months 3 post-procedure]
• Change from Baseline in Antihypertensive Medication Use [Срок оценки: Baseline to hospital discharge or Day 7 (whichever occurs first), and to Months 3 post-procedure]
• change from baseline in the time in target range of 24 hour ambulatory blood pressure [Срок оценки: Months 3 post-procedure]

Критерии участия

Критерии включения

• Male or female, aged 18 to 65 years inclusive
• Hypertension duration longer than 3 months
• Hypertensive subjects who have been stopped taking antihypertensive drugs continuously and stably for at least 4 weeks or who do not take antihypertensive drugs , with office systolic/diastolic blood pressure still ≥140/90 mmHg and <160/100 mmHg, and 24-hour ambulatory mean systolic /diastolic pressure ≥130/80 mmHg and <140/90 mmHg;
• 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 or eGFR<40mL/min/1.73m2。
• 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.
• 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.
• Concomitant severe diseases that may interfere with study participation or affect survival, such as malignancy or AIDS.
• 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

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07664787 · Ruijin2026-293

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗