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| Name | Class |
|---|---|
| Guangdong Provincial People's Hospital | OTHER |
| Shanghai Tongji Hospital, Tongji University School of Medicine | OTHER |
| Shandong First Medical University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal denervation | 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 and 3 months. |
|
| 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 and 3months. |
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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 in 24-h ambulatory BP at 3 months post-procedure compared between the 2 groups. | the change in 24-h ambulatory systolic/diastolic BP at 3 months post-procedure compared between the 2 groups. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Daytime and Nighttime Ambulatory Systolic /diastolic Blood Pressure (ABPM) | 24-hour mean systolic /diastolic BP measured by validated ambulatory BP monitoring; | Baseline to 3 Months |
| Percentage of Participants with 24-hour Ambulatory BP <130 /80 mmHg |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian-Zhong Xu, M.D. Ph.D | Contact | +86 21 64370045 | jianzhongxv@outlook.com |
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| Shanghai Institute of Hypertension |
| OTHER |
| Shanghai Golden Leaf MedTec Co. Ltd | INDUSTRY |
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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 BP measured by validated ambulatory BP monitoring; |
| Months 3 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 3 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 3 post-procedure |
| change from baseline in the time in target range of 24 hour ambulatory blood pressure | 24-hour mean BP measured by validated ambulatory BP monitoring; | Months 3 post-procedure |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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