Sympathetic Mapping and Ablation of Renal Nerves to Treat Uncontrolled Hypertension in Real World
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Office systolic blood pressure (OSBP)
研究概览
简要总结
This study is a multicenter, single-arm, open-label and post-market study in a real world patient population with uncontrolled hypertension to document the long-term safety and efficacy of a renal mapping/selective renal denervation (msRDN) system (SyMap Medical (Suzhou), Ltd, Suzhou, China) and conducted in accordance with the requirements by National Medical Production Administration (NMPA) of China. The msRDN system consists of a disposable renal artery radiofrequency ablation catheter (Registration No: National Medical Device Approval 20243011383), a console with both electronic stimulation and radiofrequency ablation function (Registration No: National Medical Device Approval 20243011384). The study includes prospective cohort and retrospective cohort.
Approximately1,000 patients with uncontrolled hypertension who undergo msRDN procedure will be recruited from over 30 centers in China. Subjects enrolled in the study will be followed for at least three years after msRDN procedure. This study includes patients with drug-resistant hypertension or patients who are intolerant to drug therapy and, in either case, need to reduce antihypertensive medications per the inclusion criteria defined in the protocol.
详细描述
A. **Prospective Study: ** In this cohort, the long-term safety and efficacy of the approved msRDN system will be evaluated in patients with drug-resistant hypertension or patients who are intolerant to drug therapy and, in either case, need to reduce antihypertensive medications.
Study Period and Timeline (for A. Prospective Cohort)**
Subjects included in this post-market, real-world study will be followed for at least three years after msRDN procedure. The regarding clinical parameters will be taken at baseline and at each follow-up as below:
- Visit 0: Baseline/Screening Period
- Visit 1: msRDN procedure (Day 0)
- Visit 2: 1 Month Post-msRDN (30 ± 7 days)
- Visit 3: 3 Months Post-msRDN (90 ± 14 days)
- Visit 4: 6 Months Post-msRDN (180 ± 30 days)
- Visit 5: 12 Months Post-msRDN (360 ± 30 days)
- Visit 6: 24 Months Post-msRDN (720 ± 30 days)
- Visit 7: 36 Months Post-msRDN (1080 ± 30 days)
B. **Retrospective Study:** In this cohort, the safety and efficacy of msRDN system will be evaluated in patients with drug-resistant hypertension or patients who are intolerant to drug therapy and, in either case, need to reduce antihypertensive medications, who have been treated by msRDN procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Office systolic blood pressure (OSBP)
时间窗: 6 months
The change in office systolic blood pressure between baseline and 6 months
次要结局
- Office Blood Pressure(1, 3, 6 (diastolic blood pressure), 12, 24 and 36 months)
- 24-hour Ambulatory Blood Pressure(1, 3, 6, 12, 24 and 36 months)
- Change in Antihypertensive Medications(1, 3, 6, 12, 24 and 36 months)
- Renal Function (eGFR and UACR)(1, 3, 6, 12, 24 and 36 months)
- Blood Glucos(1, 3, 6, 12, 24 and 36 months)