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.
**(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.
Subjects are withdrawn from the study due to various reasons;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;
Subjects undergoing renal denervation procedure for hypertension
Case-only
Other
SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator
DeviceRadiofrequency ablation of renal arterial sympathetic nerves
Office systolic blood pressure (OSBP)
The change in office systolic blood pressure between baseline and 6 months
Office Blood Pressure
Changes in office blood pressure (systolic and diastolic) between baseline and 1, 3, 6 (diastolic blood pressure), 12, 24 and 36 months, respectively;
24-hour Ambulatory Blood Pressure
Changes in 24-hour ambulatory blood pressure (systolic and diastolic) between baseline and 1, 3, 6, 12, 24 and 36 months, respectively;
Change in Antihypertensive Medications
Changes in antihypertensive medications between baseline and 1, 3, 6, 12, 24 and 36 months, respectively;
Renal Function (eGFR and UACR)
Changes in renal function (eGFR and UACR) between baseline and 1, 3, 6, 12, 24 and 36 months, respectively;
Success rate of msRDN procedure
The success rate was defined by whether the renal mapping/denervation catheter can be engaged in the correct position in the renal artery and renal nerve ablation procedure was successfully performed without related complications such as renal arterial perforation or renal artery embolization.
Success rate of clinical treatment
Based on succeed performance of msRDN procedure, there are no the procedure-related SAE, such as acute infection and renal dysfunction
All-cause mortality and incidence of severe renal function impairment
eGFR \< 15 mL/min/m² or requiring renal replacement therapy at 1, 3, 6, 12, 24 and 36 months after msRDN procedure;
Incidence of renal artery stenosis
Incidence of renal artery stenosis (stenosis\>70%) at 12, 24 and 36 months after msRDN procedure;
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SyMap Medical (Suzhou), Ltd.
Lead sponsor
Beijing Hisicom Tech Dvpt Inc.
Collaborator
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