SMART Study in Real World
brief 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.
detailed description
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.
\*Study Period and Timeline (for B. Retrospective Cohort) \*\* Patients who have been consented and enrolled in the study will be followed for at least three years.
In this cohort, as long as a patient meets inclusion criteria of the study and at least one clinical efficacy endpoint is recorded at ≥36 months after msRDN procedure, the data from this patient will be used for statistical analysis. During 36 month study period, data will be collected at baseline and at each follow-up point per protocol as below:
* Visit 1: msRDN procedure (Day 0) * Visit 2: 1 Month Post-msRDN (30 ± 14 days) * Visit 3: 3 Months Post-msRDN (90 ± 28 days) * Visit 4: 6 Months Post-msRDN (180 ± 28 days) * Visit 5: 12 Months Post-msRDN (360 ± 28 days) * Visit 6: 24 Months Post-msRDN (720 ± 28 days) * Visit 7: 36 Months Post-msRDN (1080 ± 28 days) Final Follow-Up
The midpoints of two adjacent follow-ups are used as the reference to determine which follow-up point the data belong to: if data are collected before the midpoint and accounted in the early follow-up；if data are collected after the midpoint and accounted in the later follow-up.
official title
Sympathetic Mapping and Ablation of Renal Nerves to Treat Uncontrolled Hypertension in Real World