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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
180
Radio-frequency ablation of renal arterial sympathetic nerves
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.
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
Time frame: Baseline to 6 months
The incidence of Major Adverse Events (MAE)
Safty outcome
Time frame: Baseline to 1 month
Reduction in office systolic and diastolic BP
Secondary outcome
Time frame: Baseline to 1, 3, 6 months post procedure
Reduction in average 24h ambulatory diastolic BP
Time frame: Baseline to 1, 3, 6 months post procedure
Reduction in home systolic and diastolic BP
Time frame: Baseline to 1, 2, 3, 4, 5, 6 months post procedure
Percentage of subjects change the number, class, dose of antihypertensive drugs
Time frame: Baseline to 1, 2, 3, 4, 5, 6 months post procedure
Difference in antihypertensive drug burden index
Time frame: Baseline to 6 months post procedure
Subjects level of TTR ( time in target BP range)
Time frame: 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.
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The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGChongqing General Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGCardiovascular Hospital Affiliated to Xiamen University
Xiamen, Fujian, China
RECRUITINGThe Second Hospital of Lanzhou University
Lanzhou, Gansu, China
RECRUITINGGuangdong Provincial People's Hospital
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGGuizhou Provincial People's Hospital
Guiyang, Guizhou, China
RECRUITINGFirst Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
RECRUITINGThe 7th People's Hospital of Zhengzhou
Zhengzhou, Henan, China
RECRUITINGZhengzhou Central Hospital
Zhenzhou, Henan, China
RECRUITINGChangzhou No.2 People's Hospital
Changzhou, Jiangsu, China
RECRUITING...and 17 more locations
Time frame: during the procedure
Incident of acute procedure safety events
Time frame: 7 days post procedure
Incident of chronic procedure safety events
Time frame: 6 months post procedure
Incidence of TTR with MAE, all cause death, stroke and myocardial infarction
Time frame: Baseline to 6 months post procedure
Incidence of adverse events
Time frame: Baseline to 6 months post procedure
Incident of serious adverse events
Time frame: Baseline to 6 months post procedure
Ablation system defect rate
Time frame: During procedure