SMART Study in Real World

Condition(s) studied

Investigational drug(s) / intervention(s)

SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator: Radiofrequency ablation of renal arterial sympathetic nerves

Study summary

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.

Eligibility

Primary outcome measure(s)

• Office systolic blood pressure (OSBP) — 6 months
  The change in office systolic blood pressure between baseline and 6 months

Trial sites (1)

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