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To verify the safety and effectiveness of the renal artery radiofrequency ablation system under the guidance of the three-dimensional cardiac electrophysiological mapping system in the renal denervation of essential hypertension.
This trial is a prospective, multi-center, randomized controlled clinical study to verify the safety and efficacy of the renal artery radiofrequency ablation system under the guidance of the three-dimensional cardiac electrophysiological mapping system in the application of renal denervation of essential hypertension,designed to include drug-control research and sham-control resarch. Provide the basis for product registration and marketing and clinical application. Drug-control research include 65 subiects (5 are subjects trained and taught by the experimental group leader unit center, 40 subjects are randomly to the renal artery ablation with durg treatment group, 20 subjects to the drug treatment group). Sham-control research include 180 subjects, will be randomly assigned according to 2:1 (120 subjects in the renal artery ablation with drug treatment group and 60 subjects in the sham procedure with drug treatment group).
Patients will be followed for blood pressure measurement and antihypertensive medication at 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, and 12 months after the procedure. Patients' urine samples will be collected for drug testing (LC-MS/MS) to determine their medication compliance in an independent laboratory.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal Denervation | Experimental | Percutaneous renal denervation using the FlashPoint radio-frequency ablation system under the Columbus 3D mapping system guidance |
|
| sham | Sham Comparator | For those subjects randomized to the sham procedure, renal artery angiography will serve as the sham procedure. Subjects maintenance of anti-hypertensive medications. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FlashPoint renal denervation system | Device | Radio-frequency ablation of renal arterial sympathetic nerves |
|
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour ambulatory mean systolic blood pressure reduction | The primary effectiveness endpoint is change in 24-hour ambulatory mean systolic blood pressure from baseline to 6 months post-randomization | Baseline to 6 months |
| The incidence of Major Adverse Events (MAE) | Safty outcome | Baseline to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in office systolic and diastolic BP | Secondary outcome | Baseline to 1, 3, 6 months post procedure |
| Reduction in average 24h ambulatory diastolic BP | Baseline to 1, 3, 6 months post procedure |
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Inclusion Criteria:
Exclusion Criteria:
Renal artery anatomy failures include:
Glomerular filtration rate (eGFR) <45mL/min/1.73m2 (MDRD formula);
History of hospitalization for hypertensive crisis in the past year;
During the screening and lead-in period, the patient used antihypertensive drugs other than the standard antihypertensive drugs prescribed in this study protocol;
Nocturnal sleep apnea syndrome requires mechanical ventilation (such as tracheostomy);
Those who have or are currently suffering from the following diseases or conditions:
Patients with secondary hypertension.
Patients who are deemed inappropriate to participate in this trial by other investigators.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuehui Yin, MD | Contact | +86 13508335502 | Yinyh@hospital.cqmu.edu.cn | |
| Yingxian Sun, MD | Contact | +86 13804068889 | yxsun@cmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | 400037 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41954001 | Derived | Long Y, Lai Y, Ren Y, Ma X, Li D, Chen L, Liao X, Xia T, Liu Z, Ling Z, Chen Y, Zhou H, Yin Y. Aorticorenal Ganglion Ablation Enhances Blood Pressure Reduction After Renal Denervation. Hypertension. 2026 Jul;83(7):e26719. doi: 10.1161/HYPERTENSIONAHA.125.26719. Epub 2026 Apr 9. | |
| 39014117 | Derived | Ogoyama Y, Kario K. Differences in the effectiveness and safety of different renal denervation devices. Hypertens Res. 2024 Oct;47(10):2678-2684. doi: 10.1038/s41440-024-01801-9. Epub 2024 Jul 16. |
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| Sham | Other | After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal. |
|
| Reduction in home systolic and diastolic BP | Baseline to 1, 2, 3, 4, 5, 6 months post procedure |
| Percentage of subjects change the number, class, dose of antihypertensive drugs | Baseline to 1, 2, 3, 4, 5, 6 months post procedure |
| Difference in antihypertensive drug burden index | Baseline to 6 months post procedure |
| Subjects level of TTR ( time in target BP range) | Baseline to 6 months post procedure |
| Success rate of the renal interventional therapy procedure | Procedure success rate defined as successful introduction of the catheter, navigation to the treatment site, and there are no procedure-related SAE. | during the procedure |
| Incident of acute procedure safety events | 7 days post procedure |
| Incident of chronic procedure safety events | 6 months post procedure |
| Incidence of TTR with MAE, all cause death, stroke and myocardial infarction | Baseline to 6 months post procedure |
| Incidence of adverse events | Baseline to 6 months post procedure |
| Incident of serious adverse events | Baseline to 6 months post procedure |
| Ablation system defect rate | During procedure |
| Chongqing General Hospital | Recruiting | Chongqing | Chongqing Municipality | 401147 | China |
| Cardiovascular Hospital Affiliated to Xiamen University | Recruiting | Xiamen | Fujian | 361016 | China |
| The Second Hospital of Lanzhou University | Recruiting | Lanzhou | Gansu | China |
| Guangdong Provincial People's Hospital | Not yet recruiting | Guangzhou | Guangdong | 510080 | China |
| Guizhou Provincial People's Hospital | Recruiting | Guiyang | Guizhou | 550002 | China |
| First Affiliated Hospital of Harbin Medical University | Recruiting | Harbin | Heilongjiang | 150001 | China |
| The 7th People's Hospital of Zhengzhou | Recruiting | Zhengzhou | Henan | 450016 | China |
| Zhengzhou Central Hospital | Recruiting | Zhenzhou | Henan | China |
| Changzhou No.2 People's Hospital | Recruiting | Changzhou | Jiangsu | 213003 | China |
| Ansteel Group General Hospital | Not yet recruiting | Anshan | Liaoning | China |
| The First Affiliated Hospital of Dalian Medical University | Not yet recruiting | Dalian | Liaoning | 116014 | China |
| The First Hospital of China Medical University | Recruiting | Shengyang | Liaoning | 110001 | China |
| The People's Hospital of Liaoning Province | Recruiting | Shenyang | Liaoning | 110017 | China |
| Weifang People's Hospital | Recruiting | Weifang | Shandong | China |
| Shanghai General Hospital | Recruiting | Shanghai | Shanghai Municipality | 201620 | China |
| The Second Affiliated Hospital of Air Force Medical University of PLA | Recruiting | Xi’an | Shanxi | 710038 | China |
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
| First Affiliated Hospital of Chengdu Medical College | Recruiting | Chengdu | Sichuan | China |
| The Affiliated Hospital of Southwest Medical University | Recruiting | Luzhou | Sichuan | 646099 | China |
| Mianyang Central Hospital | Recruiting | Mianyang | Sichuan | 621000 | China |
| Tianjin Chest Hospital | Recruiting | Tianjin | Tianjin Municipality | 300300 | China |
| Tianjin First Central Hospital | Recruiting | Tianjin | Tianjin Municipality | 300384 | China |
| First Affiliated Hospital of Xinjiang Medical University | Not yet recruiting | Ürümqi | Xinjiang | China |
| Yan'an Affiliated Hospital of Kunming Medical University | Recruiting | Kunming | Yunnan | China |
| The First Affiliated Hospital of Ningbo University | Recruiting | Ningbo | Zhejiang | 315016 | China |
| Shenzhen Guangming District People's Hospital | Recruiting | Shenzhen | China |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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