NCT06780696Not yet recruiting
SMART Study in Real World
Sympathetic Mapping and Ablation of Renal Nerves to Treat Uncontrolled Hypertension in Real World
Source: ClinicalTrials.gov · Last updated 17 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 13 Jan 2025
- Start date
- Feb 2025
- Primary completion date
- Dec 2028
- Lead sponsor
- SyMap Medical (Suzhou), Ltd.
- Diseases
- High blood pressure
- NCT number
- NCT06780696
What you commit to
- Study type: Observational
- Planned participants: 1000
- From Feb 2025 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- \*\*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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.