SMART Study in Real World (SMART-RW)

Sympathetic Mapping and Ablation of Renal Nerves to Treat Uncontrolled Hypertension in Real World

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension; Resistant Hypertension; Uncontrolled Hypertension; Reduce Antihypertensive Drug Burden
• Intervention / Treatment: Device: SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Jie WANG, MD, PhD; Phone Number: +86-13511604566; Email: jay329329@yahoo.com
• Study Contact Backup: Name: JingJing ZHANG, BM; Phone Number: +8613914047970; Email: jjzhang@symapmedical.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100031
      • Peking University First Hospital
      • Contact: Wei MA, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects undergoing renal denervation procedure for hypertension

Description

1. **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.

2. **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.

3. **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;

4. **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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator; Radiofrequency ablation of renal arterial sympathetic nerves
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Office systolic blood pressure (OSBP)	The change in office systolic blood pressure between baseline and 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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;	1, 3, 6 (diastolic blood pressure), 12, 24 and 36 months
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;	1, 3, 6, 12, 24 and 36 months
Change in Antihypertensive Medications	Changes in antihypertensive medications between baseline and 1, 3, 6, 12, 24 and 36 months, respectively;	1, 3, 6, 12, 24 and 36 months
Renal Function (eGFR and UACR)	Changes in renal function (eGFR and UACR) between baseline and 1, 3, 6, 12, 24 and 36 months, respectively;	1, 3, 6, 12, 24 and 36 months
Blood Glucos	Changes in blood glucose level between baseline and 1, 3, 6, 12, 24 and 36 months, respectively	1, 3, 6, 12, 24 and 36 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During the procedure
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	wiwithin 7 days after the procedure or at the time the patient is discharged from hospital
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;	1, 3, 6, 12, 24 and 36 months
Incidence of renal artery stenosis	Incidence of renal artery stenosis (stenosis>70%) at 12, 24 and 36 months after msRDN procedure;	12, 24 and 36 months
Incidence of adverse events	Incidence of adverse events and serious adverse events at 1, 3, 6, 12, 24 and 36 months after msRDN procedure.	1, 3, 6, 12, 24 and 36 months

Collaborators and Investigators

• Sponsor: SyMap Medical (Suzhou), Ltd.
• Collaborators: Beijing Hisicom Tech Dvpt Inc.
• Investigators: Principal Investigator: JianPing LI, MD, Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: January 13, 2025
• First Submitted That Met QC Criteria: January 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: hypertension; uncontrolled hypertension; resistant hypertension; reduce antihypertensive medications
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: SMART-RW-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No