Tests a renal nerve treatment device in adults with uncontrolled high blood pressure
Follows adults with uncontrolled high blood pressure treated with a catheter-based renal nerve procedure.
Plain-language title generated from the registry record
Registry title: SMART Study in Real World
Key facts
- Where
- Beijing, ChinaSee the site
Where in China
- Peking University First HospitalBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- SyMap Medical (Suzhou), Ltd.
- Trial code
- NCT06780696
- Record updated
- 17 February 2025
- Original description
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.Read full original descriptionShow less
Sympathetic Mapping and Ablation of Renal Nerves to Treat Uncontrolled Hypertension in Real World
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.
**Inclusion Criteria (for A. Prospective Cohort)**; Patients are ≥18 years old; Patients with drug-resistant hypertension patients who are intolerant to drug therapy and, in either case, need to reduce medications; Patients consent to receive msRDN treatment using the commercially available msRDN system by SyMap Medical (Suzhou), Ltd and to fulfill follow-up requirements; **Exclusion Criteria (for A. Prospective Cohort)**; Subjects are withdrawn from the study due to various reasons; Investigators, ethics committees or regulatory agencies may halt or terminate the study due to medical perspectives or ethical considerations; **Inclusion Criteria (for B. Retrospective Cohort)**; Patients are ≥18 years old; Patients with drug-resistant hypertension patients who are intolerant to drug therapy and, in either case, need to reduce medications; Patients who have been received msRDN procedure using commercially available msRDN system by SyMap Medical (Suzhou), Ltd; **Exclusion Criteria (for B. Retrospective Cohort) **; Subjects are withdrawn from the study due to various reasons; Investigators, ethics committees or regulatory agencies may halt or terminate the study due to medical perspectives or ethical considerations.