FlashPoint Renal Denervation Under Columbus 3D Mapping System Guidance for Treating Hypertension
- Conditions
- Hypertension
- Interventions
- Device: FlashPoint renal denervation system
- Registration Number
- NCT05590871
- Lead Sponsor
- Shanghai Hongdian Medical CO., LTD
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
- 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.
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Renal artery anatomy failures include:
- Renal artery diameter <4mm or treatment length <20mm;
- Renal artery stenosis >50% or renal aneurysm on either side;
- 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;
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Nocturnal sleep apnea syndrome requires mechanical ventilation (such as tracheostomy);
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Those who have or are currently suffering from the following diseases or conditions:
- Primary pulmonary hypertension (moderate to severe);
- Type I diabetes;
- History of any cerebrovascular events (eg, stroke, transient cerebral ischemic event, cerebrovascular accident) within 3 months;
- History of any serious cardiovascular event within 3 months (eg, myocardial infarction, CABG, acute heart failure requiring hospitalization (NYHA III-IV), unstable angina attack);
- 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);
- Arranged or planned surgery or cardiovascular intervention within the next 6 months;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Renal Denervation FlashPoint renal denervation system Percutaneous renal denervation using the FlashPoint radio-frequency ablation system under the Columbus 3D mapping system guidance
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Incident of serious adverse events Baseline to 6 months post procedure Ablation system defect rate During procedure Reduction in office systolic and diastolic BP Baseline to 1, 3, 6 months post procedure Secondary outcome
Reduction in average 24h ambulatory diastolic BP Baseline to 1, 3, 6 months post procedure 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 during the procedure Procedure success rate defined as successful introduction of the catheter, navigation to the treatment site, and there are no procedure-related SAE.
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
Trial Locations
- Locations (27)
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
The Second Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Chongqing General Hospital
🇨🇳Chongqing, Chongqing, China
Cardiovascular Hospital Affiliated to Xiamen University
🇨🇳Xiamen, Fujian, China
The Second Hospital of Lanzhou University
🇨🇳Lanzhou, Gansu, China
Guizhou Provincial People's Hospital
🇨🇳Guiyang, Guizhou, China
First Affiliated Hospital of Harbin Medical University
🇨🇳Ha'erbin, Heilongjiang, China
The 7th People's Hospital of Zhengzhou
🇨🇳Zhengzhou, Henan, China
Zhengzhou Central Hospital
🇨🇳Zhenzhou, Henan, China
Changzhou No.2 People's Hospital
🇨🇳Changzhou, Jiangsu, China
Ansteel Group General Hospital
🇨🇳Anshan, Liaoning, China
The First Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
The First Hospital of China Medical University
🇨🇳Shengyang, Liaoning, China
The People's Hospital of Liaoning Province
🇨🇳Shenyang, Liaoning, China
Weifang People's Hospital
🇨🇳Weifang, Shandong, China
Shanghai General Hospital
🇨🇳Shanghai, Shanghai, China
The Second Affiliated Hospital of Air Force Medical University of PLA
🇨🇳Xi'an, Shanxi, China
West China Hospital of Sichuan University
🇨🇳Chendu, Sichuan, China
First Affiliated Hospital of Chengdu Medical College
🇨🇳Chendu, Sichuan, China
The Affiliated Hospital of Southwest Medical University
🇨🇳Luzhou, Sichuan, China
Mianyang Central Hospital
🇨🇳Mianyang, Sichuan, China
Tianjin Chest Hospital
🇨🇳Tianjin, Tianjin, China
Tianjin First Central Hospital
🇨🇳Tianjin, Tianjin, China
First Affiliated Hospital of Xinjiang Medical University
🇨🇳Ürümqi, Xinjiang, China
Yan'an Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China
The First Affiliated Hospital of Ningbo University
🇨🇳Ningbo, Zhejiang, China
Shenzhen Guangming District People's Hospital
🇨🇳Shenzhen, China