Sham: 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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
* Males or females aged ≥18 and ≤70 (not pregnant, breastfeeding, and have no reproductive plan within one year);
* Patients with essential hypertension, antihypertensive drug intolerance, and willing to undergo surgical treatment;
* Ambulatory blood pressure measurement 24-hour average systolic blood pressure ≥130mmHg or daytime ≥135mmHg, and pulse pressure difference \<80 mmHg;
* A history of using antihypertensive medication within six months and blood pressure is still uncontrollable; standardized medication (at least two drugs) for at least 28 days before enrollment, and medication compliance ≥ 80%, office systolic blood pressure (OSBP) ) ≥ 150 mmHg and \<180 mmHg, diastolic blood pressure (DBP) ≥ 90 mmHg;
* The patients agree to participate in this clinical trial and sign the informed consent form, agreeing to follow-up evaluation under the requirements of the verification protocol.
Exclusion Criteria:
* Renal artery anatomy failures include:
1. Renal artery diameter \<4mm or treatment length \<20mm;
2. Renal artery stenosis \>50% or renal aneurysm on either side;
3. A history of renal artery intervention, including balloon angioplasty or stenting or RDN;
* 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:
1. Primary pulmonary hypertension (moderate to severe);
2. Type I diabetes;
3. History of any cerebrovascular events (eg, stroke, transient cerebral ischemic event, cerebrovascular accident) within 3 months;
4. History of any serious cardiovascular event within 3 months (eg, myocardial infarction, CABG, acute heart failure requiring hospitalization (NYHA III-IV), unstable angina attack);
5. Factors that interfere with blood pressure measurement in any case (eg, patients with severe peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, severe anemia);
6. Arranged or planned surgery or cardiovascular intervention within the next 6 months;
7. Patients with malignant tumors and end-stage diseases who survival period is less than 1year;
* Patients with secondary hypertension.
* Patients who are deemed inappropriate to participate in this trial by other investigators.
Primary outcome measure(s)
24-hour ambulatory mean systolic blood pressure reduction — Baseline to 6 months The primary effectiveness endpoint is change in 24-hour ambulatory mean systolic blood pressure from baseline to 6 months post-randomization
The incidence of Major Adverse Events (MAE) — Baseline to 1 month Safty outcome
Trial sites (27)
Facility
City
Region
Status
The Second Affiliated Hospital of Chongqing Medical University
Chongqing
Chongqing Municipality
Recruiting
Chongqing General Hospital
Chongqing
Chongqing Municipality
Recruiting
Cardiovascular Hospital Affiliated to Xiamen University
Xiamen
Fujian
Recruiting
The Second Hospital of Lanzhou University
Lanzhou
Gansu
Recruiting
Guangdong Provincial People's Hospital
Guangzhou
Guangdong
Not Yet Recruiting
Guizhou Provincial People's Hospital
Guiyang
Guizhou
Recruiting
First Affiliated Hospital of Harbin Medical University
Harbin
Heilongjiang
Recruiting
The 7th People's Hospital of Zhengzhou
Zhengzhou
Henan
Recruiting
Zhengzhou Central Hospital
Zhenzhou
Henan
Recruiting
Changzhou No.2 People's Hospital
Changzhou
Jiangsu
Recruiting
Ansteel Group General Hospital
Anshan
Liaoning
Not Yet Recruiting
The First Affiliated Hospital of Dalian Medical University
Dalian
Liaoning
Not Yet Recruiting
The First Hospital of China Medical University
Shengyang
Liaoning
Recruiting
The People's Hospital of Liaoning Province
Shenyang
Liaoning
Recruiting
Weifang People's Hospital
Weifang
Shandong
Recruiting
Shanghai General Hospital
Shanghai
Shanghai Municipality
Recruiting
The Second Affiliated Hospital of Air Force Medical University of PLA
Xi’an
Shanxi
Recruiting
West China Hospital of Sichuan University
Chengdu
Sichuan
Recruiting
First Affiliated Hospital of Chengdu Medical College
Chengdu
Sichuan
Recruiting
The Affiliated Hospital of Southwest Medical University
Luzhou
Sichuan
Recruiting
Mianyang Central Hospital
Mianyang
Sichuan
Recruiting
Tianjin Chest Hospital
Tianjin
Tianjin Municipality
Recruiting
Tianjin First Central Hospital
Tianjin
Tianjin Municipality
Recruiting
First Affiliated Hospital of Xinjiang Medical University
Ürümqi
Xinjiang
Not Yet Recruiting
Yan'an Affiliated Hospital of Kunming Medical University
Kunming
Yunnan
Recruiting
The First Affiliated Hospital of Ningbo University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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