SMART Study in Real World

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.

• **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.