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| Name | Class |
|---|---|
| Beijing Anzhen Hospital | OTHER |
| Shanghai Zhongshan Hospital | OTHER |
| Guangdong Provincial People's Hospital | OTHER |
| The Second Affiliated Hospital of Harbin Medical University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal Denervation (RDN) | Experimental | 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 |
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| Parallel control with sham operation | Sham Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Six-channel RF Renal Denervation System | Device | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in 24-hour Ambulatory Systolic Blood Pressure at Month 6 (ABPM) | 24-hour mean systolic BP measured by validated ambulatory BP monitoring; change is Month 6 minus Baseline. | Baseline to Month 6 post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in 24-hour Ambulatory Diastolic Blood Pressure at Month 6 (ABPM) | 24-hour mean systolic BP measured by validated ambulatory BP monitoring; | Baseline to Month 6 post-procedure |
| Change from Baseline in 24-hour Ambulatory Blood Pressure (including both systolic and diastolic BP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, affiliated to Capital Medical University | Beijing | Beijing Municipality | 100029 | China |
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| OTHER |
| West China Hospital | OTHER |
| Jiangxi Provincial People's Hopital | OTHER |
| Navy General Hospital, Beijing | OTHER |
| Qilu Hospital of Shandong University | OTHER |
| Xijing Hospital | OTHER |
| Fujian Provincial Hospital | OTHER |
| First Affiliated Hospital of Fujian Medical University | OTHER |
| Henan Provincial People's Hospital | OTHER |
| Hebei Provincial People's Hospital | UNKNOWN |
| Anhui Provincial Hospital | OTHER_GOV |
| The First Hospital of Jilin University | OTHER |
| First Affiliated Hospital of Xinjiang Medical University | OTHER |
| First Affiliated Hospital of Guangxi Medical University | OTHER |
| Qianfoshan Hospital | OTHER |
| Ningbo Medical Center Lihuili Hospital | OTHER_GOV |
| Mianyang Central Hospital | OTHER |
| The Third People's Hospital of Chengdu | OTHER |
| General Hospital of the Eastern Theater Command | UNKNOWN |
| China-Japan Union Hospital, Jilin University | OTHER |
| Shanxi Bethune Hospital | OTHER |
| Second Hospital of Shanxi Medical University | OTHER |
| Yan'an Affiliated Hospital of Kunming Medical University | OTHER |
Prospective, Multicenter, Randomized, Parallel-Controlled,The trial will enroll 236 subjects (trial group: control group = 1:1).
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The trial will enroll 236 subjects (trial group: control group = 1:1)
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| Parallel controln with sham operation(there is no rade and/or generic name,It is a blank control sham operation) | Procedure | 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. |
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24-hour mean systolic BP measured by validated ambulatory BP monitoring; |
| Baseline to Months 1, 3, 12, 24, and 36 post-procedure |
| Change from Baseline in Daytime and Nighttime Ambulatory Systolic Blood Pressure (ABPM) | 24-hour mean systolic BP measured by validated ambulatory BP monitoring; | 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) | measured by validated office blood pressure monitoring | Baseline to Months 1, 3, 6, 12, 24, and 36 post-procedure |
| Percentage of Participants with 24-hour Ambulatory Systolic BP <130 mmHg | 24-hour mean systolic BP measured by validated ambulatory BP monitoring; | 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) | measured by validated office blood pressure monitoring | Months 1, 3, 6, 12, 24, and 36 post-procedure |
| Responder Rate: ≥5 mmHg Reduction in 24-hour Ambulatory Systolic BP | Proportion of participants with a reduction ≥5 mmHg from baseline in 24-hour mean systolic BP by ABPM. | Months 1, 3, 6, 12, 24, and 36 post-procedure |
| Change from Baseline in Antihypertensive Medication Use | Change in the number of concurrently prescribed antihypertensive agents . | 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) | by Echocardiography | Baseline to Months 1, 3, 6, 12, 24, and 36 post-procedure |
| Change from Baseline in Heart Rate (by ECG) | Resting heart rate measured by standard 12-lead ECG; change is Follow-up minus Baseline. | Baseline to Months 1, 3, 6, 12, 24, and 36 post-procedure |
| Device and Procedure Success | Successful completion of intended renal denervation ablations in eligible segments of the renal arteries without device malfunction requiring replacement or procedure abortion. | Intra-procedure (Day 0) |
| Periprocedural major adverse event (MAE) rate | Hospitalization for a clinically significant hypotensive or hypertensive event; Vascular complications requiring surgical repair, endovascular therapy, thrombin injection, or blood transfusion; Renal artery dissection or perforation requiring intervention; Significant embolic events causing end-organ damage or requiring intervention to prevent it; Severe renal impairment (>50% decrease in eGFR or >50% increase in serum creatinine from baseline) or ESRD (eGFR <15 mL/min/1.73 m²); All-cause death; New renal artery stenosis ≥70% (confirmed by angiography). | Baseline to 30 days post-procedure |
| Safety event rates | Interventional complications: pseudoaneurysm, thrombosis, dissection, AV fistula, rupture or perforation, renal artery stenosis. All-cause mortality. MACCE: stroke (ischemic or hemorrhagic), ACS (AMI or unstable angina), cardiovascular death. Severe renal dysfunction (eGFR decrease >50% or creatinine increase >50% from baseline) or ESRD (eGFR <15 mL/min/1.73 m²). New renal artery stenosis ≥70% within 6 months (confirmed by angiography). | Baseline to Months 36 post-procedure |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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