Main Objective: To Evaluate the Long-term Safety and Efficacy of Using the Netrod-RDN Renal Artery Radiofrequency Ablation System in Treating Patients With Refractory Hypertension and Those With Hypertension Who Are Intolerant to Medication in the Real-world Setting
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Change from Baseline in 24-hour Ambulatory Blood Pressure (including both systolic and diastolic BP)
研究概览
简要总结
This study is an observational one, collecting real-world data generated in routine clinical treatment. The Netrod-RDN renal artery radiofrequency ablation system (including the renal artery radiofrequency ablation device and the disposable mesh renal artery radiofrequency ablation catheter) produced and provided by Shanghai Meiliweiye Medical Technology Co., Ltd. was used to perform percutaneous renal denervation (RDN) on patients with refractory hypertension and drug intolerance in the real world. Refractory hypertension is defined as patients whose blood pressure remains uncontrolled despite taking three or more antihypertensive drugs (including one diuretic) for more than three months; drug intolerance refers to patients who have contraindications to drugs or cannot tolerate drug administration due to adverse drug reactions.
详细描述
All the subjects who were enrolled and received RDN treatment were followed up until 36 months after the surgery. Blood pressure was measured and the antihypertensive effect was evaluated at regular intervals at 7 days after RDN or before discharge (whichever came first), 30 days (±7 days) after the surgery, 3 months (±14 days), 6 months (±30 days), 12 months (±30 days), 24 months (±30 days), and 36 months (±30 days) during the follow-up. Dynamic safety data monitoring was conducted for the subjects throughout the entire study process.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Patients who have already used or are planning to use the Netrod-RDN renal artery radiofrequency ablation system for RDN surgery;
- •(2) Patients understand the requirements and treatment of this clinical study, agree to follow the requirements of this clinical study for follow-up, and sign the informed consent form before undergoing any special examinations and operations related to the study.
排除标准
- •Patients with contraindications for RDN surgery and/or those who the researchers consider unsuitable for RDN or who do not wish to participate in this study.
研究组 & 干预措施
Refractory hypertension and hypertension with drug intolerance Patient
For patients who have been taking more than three types of antihypertensive drugs (including one diuretic) for more than 3 months and whose blood pressure has not been controlled adequately; drug intolerance refers to patients who cannot tolerate the medication due to drug contraindications or adverse drug reactions.
干预措施: Percutaneous nephrolysis combined with sympathetic nerve ablation (RDN) procedure (Device)
结局指标
主要结局
Change from Baseline in 24-hour Ambulatory Blood Pressure (including both systolic and diastolic BP)
时间窗: Time Frame: Baseline to Month 6 post-procedure.
次要结局
- Change from Baseline in Antihypertensive Medication Load (calculated based on the dosage and types of antihypertensive agents).(Baseline to Day 7 or hospital discharge (whichever occurs first), and Months 1, 3, 6, 12, 24, and 36 post-procedure.)
- Proportion of Participants Achieving Blood Pressure Targets (Office, Home, and 24-hour Ambulatory; including both systolic and diastolic BP)(At the same assessment time points as the above BP measurements (office, home, and 24-hour ambulatory BP).)
- Change from Baseline in Office Blood Pressure (including both systolic and diastolic BP)(Baseline to Day 7 or hospital discharge (whichever occurs first), and Months 1, 3, 6, 12, 24, and 36 post-procedure.)
- Change from Baseline in 24-hour Ambulatory Blood Pressure (including both systolic and diastolic BP)(Baseline to 3, 12, 24, and 36 months post-procedure)
- 24-hour Time in Target Range for Ambulatory Blood Pressure (percentage of time meeting daytime <135/85 mmHg and nighttime <120/70 mmHg thresholds)(Months 6, 12, and 36 post-procedure.)
- Change from Baseline in SF-12 Health-Related Quality of Life Score (for heart failure subgroup only)(Baseline to Months 12 and 36 post-procedure.)
- Safety event rates(Baseline to Month 36 post-procedure)
- Change from Baseline in Home Blood Pressure (including both systolic and diastolic BP)(Time Frame: Baseline to Months 1, 3, 6, 12, 24, and 36 post-procedure.)
- Change from Baseline in Six-Minute Walk Distance (meters; heart failure subgroup only)(Baseline to Months 6, 12, 24, and 36 post-procedure.)
- Periprocedural major adverse event (MAE) rate(Baseline to 30 days post-procedure)