A Randomized Trial of Six-Channel RF Ablation System for Renal Denervation in Uncontrolled Hypert… (NCT07130955) | Clinical Trial Compass
By InvitationNot Applicable
A Randomized Trial of Six-Channel RF Ablation System for Renal Denervation in Uncontrolled Hypertension and Chronic Kidney Disease
China236 participantsStarted 2025-08-08
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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;
✓. 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.
Exclusion criteria
✕. 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).
✕
What they're measuring
1
Change from Baseline in 24-hour Ambulatory Systolic Blood Pressure at Month 6 (ABPM)
. 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.