3D Cardiac Electrophysiological Mapping System on Renal Artery Radiofrequency Ablation System for Hypertension: a Prospective, Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 27
- 主要终点
- 24-hour ambulatory mean systolic blood pressure reduction
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
- •Nocturnal sleep apnea syndrome requires mechanical ventilation (such as tracheostomy);
- •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.
研究组 & 干预措施
Renal Denervation
Percutaneous renal denervation using the FlashPoint radio-frequency ablation system under the Columbus 3D mapping system guidance
干预措施: FlashPoint renal denervation system (Device)
sham
For those subjects randomized to the sham procedure, renal artery angiography will serve as the sham procedure.
Subjects maintenance of anti-hypertensive medications.
干预措施: Sham (Other)
结局指标
主要结局
24-hour ambulatory mean systolic blood pressure reduction
时间窗: 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)
时间窗: Baseline to 1 month
Safty outcome
次要结局
- Reduction in average 24h ambulatory diastolic BP(Baseline to 1, 3, 6 months post procedure)
- Reduction in office systolic and 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)
- 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)